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DRONABINOL a synthetic THC & Cannabis studies completed

Dronabinol medication is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients infected with HIV (the virus that causes AIDS). Dronabinol (also called THC) is a man-made form of the active natural substance in cannabis.

Undated - Overview - GENERIC NAME: DRONABINOL - ORAL (dro-NAB-in-all) BRAND NAME(S): Marinol

1977 - Study - Effects of dronabinol on anorexia and disturbed behavior in patients with Alzheimer's disease

1990 - Study - Dronabinol enhancement of appetite in cancer patients

1991 - Study - Dronabinol and prochlorperazine in combination

1991 - Study - Recent clinical experience with dronabinol

1992 - Study - Dronabinol effects on weight in patients with HIV infection

1992 - Study - Dronabinol stimulates appetite and causes weight gain in HIV patients

1993 - Study - Effect of dronabinol on nutritional status in HIV infection

1995 - Study - Treatment of spasticity in spinal cord injury with dronabinol

1997 - Study - Nausea relieved by tetrahydrocannabinol (dronabinol)

1997 - Study ~ Effects of dronabinol on anorexia and disturbed behavior in patients with Alzheimer's disease.

1997 - Study ~ Intractable nausea and vomiting due to gastrointestinal mucosal metastases relieved by tetrahydrocannabinol (dronabinol).

1998 - Study ~ Abuse potential of dronabinol (Marinol).

2001 - Study ~ Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review.

2002 - Study - Dronabinol in patients with intractable pruritus secondary to cholestatic liver disease

2003 - Study - Dronabinol in the treatment of refractory agitation in Alzheimer's disease

2003 - Study - Safety and efficacy of dronabinol in the treatment of agitation in patients with Alzheimer's disease

2003 - Study ~ Cannabis and the brain.

2003 - Study ~ Cannabinoid rotation in a young woman with chronic cystitis

2003 - Study ~ Safety and efficacy of dronabinol in the treatment of agitation in patients with Alzheimer’s disease A retrospective chart review

2003 - Study ~ Open-label study of dronabinol in the treatment of refractory agitation in Alzheimer’s disease: a pilot study

2003 - Study ~ Therapeutic potential of cannabinoids in CNS disease.

2004 - Monograph ~ MARINOL® (Dronabinol) Capsules

2004 - Study ~ Does the cannabinoid dronabinol reduce central pain in multiple sclerosis? Randomised double blind placebo controlled crossover trial.

2004 - Study ~ A Novel Intervention for the Treatment of Gout in an Elderly Rehabilitation Patient in Whom Conventional Treatment was Ineffective

2004 - Study ~ Cannabinoid agonists in the treatment of blepharospasm--a case report study.

2006 - Study ~ US Patent Application 20060160888 - Room-temperature stable dronabinol formulations

2006 - Study - Dronabinol for supportive therapy in patients with malignant melanoma and liver metastases

2006 - Study - Dronabinol reduces signs and symptoms of idiopathic intracranial hypertension

2006 - Study ~ Effect of a cannabinoid agonist on gastrointestinal transit and postprandial satiation in healthy human subjects: a randomized, placebo-controlled study

2006 - News - Cannabinoid Activator Mellows Out Colon

2006 - News ~ Cannabis Chemicals May Alleviate Post-Eating Stomach Cramps

2007 - Study - Dronabinol an effective appetite stimulant?

2007 - Study - Efficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone for delayed chemotherapy-induced nausea and vomiting

2007 - Study - Dronabinol and marijuana in HIV-positive marijuana smokers: caloric intake, mood, and sleep

2007 - Study - Dronabinol and retinal hemodynamics in humans

2007 - Study - Dronabinol and marijuana in HIV-positive marijuana smokers. Caloric intake, mood, and sleep

2007 - Study ~ Effects of a cannabinoid receptor agonist on colonic motor and sensory functions in humans: a randomized, placebo-controlled study

2007 - Study ~ US Patent Application 20070020193 - Dronabinol compositions and methods for using same

2007 - Study ~ Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting: beyond prevention of acute emesis.

2007 - Study ~ Symptomatic treatment of multiple sclerosis using cannabinoids: recent advances.

2007 - Study ~ Anorexia of aging in long term care: is dronabinol an effective appetite stimulant?--a pilot study.

2008 - Study - Current Status of Cannabis Treatment of Multiple Sclerosis with an Illustrative Case Presentation of a Patient with MS, Complex Vocal Tics, Paroxysmal Dystonia, and Marijuana Dependence Treated with Dronabinol

2008 - Study ~ Cannabinoids in the management of difficult to treat pain

2008 - Study ~ US Patent Application 20080112895 - Aqueous dronabinol formulations

2008 - Letter - Improvement in Refractory Obsessive Compulsive Disorder With Dronabinol

2009 - Study - Effects of {Delta}9-tetrahydrocannabinol on reward and anxiety in rats exposed to chronic unpredictable stress

2009 - Study - Synthetic delta-9-tetrahydrocannabinol (dronabinol) can improve the symptoms of schizophrenia

2009 - Study ~ Emerging strategies for exploiting cannabinoid receptor agonists as medicines.

2009 - Study ~ Cluster attacks responsive to recreational cannabis and dronabinol.

2009 - News ~ The FDA has written documentation that patients can overdose on Marinol and that it can be lethal

2010 - Study ~ Use of dronabinol (delta-9-THC) in autism: A prospective single-case-study with an early infantile autistic child

2010 - Study ~ Delta9-tetrahydrocannabivarin testing may not have the sensitivity to detect marijuana use among individuals ingesting dronabinol.

2010 - Study ~ Effect of dronabinol on central neuropathic pain after spinal cord injury: a pilot study.

2010 - Study ~ Efficacy and tolerability of high-dose dronabinol maintenance in HIV-positive marijuana smokers: a controlled laboratory study.

2011 - Study ~ Room-temperature stable dronabinol formulations - Patent NZ555701 (A) ― 2011-05-27

2011 - Study ~ Dronabinol, a cannabinoid agonist, reduces hair pulling in trichotillomania: a pilot study.

2011 - Study ~ Cannabinoids in children

2011 - Study ~ Pharmacogenetic Trial of a Cannabinoid Agonist Shows Reduced Fasting Colonic Motility in Patients with Non-Constipated Irritable Bowel Syndrome.

2011 - Study ~ Drunk versus drugged: How different are the drivers?

2011 - Study ~ Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.

2011 - News ~ What Are Prescription Drugs That Are a Substitute for Marijuana?

2011 - News ~ Science: THC effective in trichotillomania symptoms in a pilot study

2012 - Monograph ~ DRONABINOL capsule [Watson Laboratories, Inc.]

2012 - Study ~ Randomized pharmacodynamic and pharmacogenetic trial of dronabinol effects on colon transit in irritable bowel syndrome-diarrhea.

2012 - Study ~ Subjective, cognitive and cardiovascular dose-effect profile of nabilone and dronabinol in marijuana smokers.

2012 - Study ~ Genetic Epidemiology and Pharmacogenetics in Irritable Bowel Syndrome.

2012 - Study ~ Heat Exposure of Cannabis sativa Extracts Affects the Pharmacokinetic and Metabolic Profile in Healthy Male Subjects.

2012 - Study ~ Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting.

2012 - Study ~ Irritable Bowel Syndrome: Methods, Mechanisms, and Pathophysiology. Genetic epidemiology and pharmacogenetics in irritable bowel syndrome


 

Journal of Cannabis Therapeutics Studies in Endogenous, Herbal & Synthetic Cannabinoids Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic PotentialEffects of a synthetic cannabinoid on the reinforcing efficacy of self-administered ethanol in rats.Cannabinoids in Nature and MedicineCannabinoids (Handbook of Experimental Pharmacology)
 

 

 

 

 
 
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Dronabinol in the treatment of refractory agitation in Alzheimer's disease

TitleOpen-label study of dronabinol in the treatment of refractory agitation in Alzheimer’s disease: a pilot study
Author(s)Ross JS, Shua-Haim JR
Journal, Volume, IssueAbstract, American Society of Consultant Pharmacists' 34th Annual Meeting, November 12-15, 2003.
Major outcome(s)Significant reduction of agitation
 
IndicationAlzheimer's diseaseAbstract
MedicationDelta-9-THC

Objectives: Primary, to investigate the efficacy of two doses of dronabinol for the treatment of behavioral agitation in community-dwelling patients with Alzheimer’s disease (AD). Secondary, to evaluate two doses of dronabinol in improving the patient’s global functioning and to determine the effects of two doses of dronabinol on the caregiver’s burden, strain (distress), and quality of life.

Design: A phase II, open-label, eight-week study in a total of 54 patients with AD. Twenty-seven patients were randomly assigned to Group 1—dronabinol 2.5 mg bid and 27 to Group 2—dronabinol 5.0 mg bid. The primary efficacy measurement was the Cohen-Mansfield Agitation Inventory (CMAI), a 38-item rating scale that evaluates the prevalence of pathological and disruptive behaviors, rating each on a seven-point scale of frequency ranging from 0 to 6. The secondary efficacy measurements were the Caregiver’s Burden Inventory (CBI), CGI Severity of Alzheimer’s Disease (CGI-S AD), Instrumental Activities of Daily Living scale (IADL), and Mini-Mental State Examination (MMSE).

Results: Significant reductions in CMAI scores were observed at both dronabinol dose levels (2.5: P<0.001, 5.0: P=0.024). The difference between the two groups was not statistically significant. Percent reductions in CMAI scores were statistically significant for both groups (2.5: P<0.001, 5.0: P=0.048). There was a trend toward a decrease in CBI scores, with no statistical difference between treatment groups. There was a trend toward a decrease in CGI-S AD scores in the dronabinol 5.0-mg bid group. There was a trend toward an increase in IADL scores with no difference between groups. There was no difference between groups in MMSE.
Conclusion: The results from the CMAI assessment indicated that dronabinol at both 2.5 mg bid and 5.0 mg bid were effective treatments for behavioral agitation in community-dwelling AD patients. There was not a significant difference between the doses of dronabinol in CMAI scores and most secondary efficacy parameters.

Benefit: Dronabinol was found to be an effective treatment for behavioral agitation in community-dwelling patients with AD.


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Effects of dronabinol on anorexia and disturbed behavior in patients with Alzheimer's disease

TitleEffects of dronabinol on anorexia and disturbed behavior in patients with Alzheimer's disease.
Author(s)Volicer L, Stelly M, Morris J, McLaughlin J, Volicer BJ
Journal, Volume, IssueInternational Journal of Geriatric Psychiatry 1997;12(9):913-919
Major outcome(s)higher weight gain with THC; reduction of disturbed behaviour with THC
 
IndicationAppetite loss/weight loss;Alzheimer's diseaseAbstract
MedicationDelta-9-THC

A placebo-controlled crossover design, with each treatment period lasting 6 weeks, was used to investigate effects of dronabinol in 15 patients with a diagnosis of probable Alzheimer's disease who were refusing food. Eleven patients completed both study periods; one patient who died of a heart attack 2 weeks before the end of the study was also included in the analysis. The study was terminated in 3 patients: one developed a grand mal seizure and 2 developed serious intercurrent infections. Body weight of study subjects increased more during the dronabinol treatment than during the placebo periods. Dronabinol treatment decreased severity of disturbed behavior and this effect persisted during the placebo period in patients who received dronabinol first. Adverse reactions observed more commonly during the dronabinol treatment than during placebo periods included euphoria, somnolence and tiredness, but did not require discontinuation of therapy. These results indicate that dronabinol is a promising novel therapeutic agent which may be useful not only for treatment of anorexia but also to improve disturbed behavior in patients with Alzheimer's disease.


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Route(s)Oral
Dose(s) 
Duration (days)42
Participants15 patients with Alzheimer's disease
DesignControlled study
Type of publication 
Address of author(s)E. N. Rogers Memorial Veterans Hospital, Geriatric Research Education Clinical Center, Bedford, MA, USA
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Dronabinol an effective appetite stimulant?

TitleAnorexia of aging in long term care: is dronabinol an effective appetite stimulant? - a pilot study.
Author(s)Wilson MM, Philpot C, Morley JE
Journal, Volume, IssueJ Nutr Health Aging. 2007 Mar-Apr;11(2):195-8.
Major outcome(s)A trend towards weight gain
 
IndicationAppetite loss/weight lossAbstract
MedicationDelta-9-THC

Introduction: Anorexia and subsequent weight loss increase the risk of death in long term care (LTC) residents. In patients who fail to respond to nutritional intervention, orexigenic drugs are sometimes prescribed. There is limited data regarding the safety and efficacy of these drugs in older adults. Objective: To examine the effect of a 12-week course of dronabinol on LTC residents with anorexia and significant weight loss. Design, setting, participants: Retrospective observational study on residents in five LTC facilities in a major metropolitan area. Results: Twenty-eight subjects (22F, 6M) were involved in the study. Mean age 79.5 +/- 19.8 years (range 46-98y). Mean body weight, serum albumin and serum prealbumin at baseline were 105.7 +/- 24.7 lbs, 3.39 +/- 0.47 g/dl and 22.15 +/- 7.92 mg/dl respectively. 15 subjects (53.5%) gained weight on dronabinol, of which 10 (67%) gained more than 5lbs and 6(40%) gained more than 10lbs. Five (33%) subjects gained less than 5lbs. Residents who lost weight on dronabinol were younger than those who gained weight (70.9 +/- 5.62 y and 90.8 +/- 7.84 y respectively; p = 0.007) Overall, the mean weight gain on dronabinol was 3 +/- 8.01 lbs (p=0.2). Eleven subjects lost weight (mean loss 3 +/- 2.6 lbs). Of the subjects who lost weight 7 (64%) died compared with 4 (26%) in the subgroup who gained weight. Conclusions: Dronabinol therapy was well tolerated. Overall, there was a trend toward weight gain in LTC residents treated with 12 weeks of dronabinol. Failure to respond to dronabinol may indicate increased risk of death.


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Route(s)Oral
Dose(s) 
Duration (days)84
Participants28 old patients suffering from weight loss
DesignOpen study
Type of publicationMedical journal
Address of author(s)M.M.G. Wilson, MRCP, Division of Geriatric Medicine, Saint Louis University, 1402, S. Grand Blvd, Rm M238, St Louis, MO 63104, Tel: (314) 977-8404, Fax: (314) 977-8409, Email: wilsonmg@slu.edu.
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Safety and efficacy of dronabinol in the treatment of agitation in patients with Alzheimer's disease

TitleSafety and efficacy of dronabinol in the treatment of agitation in patients with Alzheimer’s disease with anorexia: A retrospective chart review
Author(s)Patel S, Shua-Haim JR, Pass M
Journal, Volume, IssueAbstract, International Psychogeriatric Association, Eleventh International Congress, 2003
Major outcome(s)Weight gain in all, reduction of agitation in 65%.
 
IndicationAppetite loss/weight loss;Alzheimer's diseaseAbstract
MedicationDelta-9-THC

Objective: to investigate the safety and efficacy of dronabinol in Alzheimer’s disease (AD) patients with agitation.
Design: retrospective review.
Materials and Methods: AD patients with anorexia, where according to family members or caregivers (staff nurses) agitation was not satisfactorily controlled, were prescribed dronabinol. All met the DSM-IV & NINCDS-ADRDA criteria for possible AD. There were no exclusion criteria. Study subjects resided in a dementia unit in assistant living facility and in a nursing home. Dronabinol, 5 mg/day in 2 divided doses was given initially & titrated up to a maximum of 10 mg/day. Cognition and function evaluated at the start and end of the study period. MMSE and ADL scales used for assessment. Concomitant medications were recorded. After 1 month of treatment, caregivers were asked to complete a questionnaire regarding their impression on treatment efficacy.
Results: 48 patients were treated with dronabinol. Average age was 77. Average MMSE was 16. All patients were treated with atypical neuroleptics. All were treated with multiple (greater than 3) medications to control behavior. All patients had diagnoses of anorexia prior to initiation of dronabinol therapy. Weight gain was reported in all patients. Agitation significantly improved in 31 (65%). In 14 (37%) there was improvement in MMSE score (average increase by 1.6 points (range +1 to +3). Functional improvement was reported in 33 (69%). 17 (35%) patients had no significant beneficial effect with regard to agitation, and their medication was discontinued within 2 weeks of initiation of treatment. No patient experienced any significant adverse event (falls, syncope, seizures or exacerbation of agitation/depression).
Conclusion: Dronabinol treatment for agitation in AD patients with anorexia was effective in 31 out of 48 of patients who were refractory to other medications. No adverse events were reported.


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Route(s)Oral
Dose(s) 
Duration (days)30
Participants48 Alzheimer patients
DesignOpen study
Type of publicationMeeting abstract
Address of author(s)Meridian Institute for Aging, Manchester Township, NJ, USA
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Effect of dronabinol on nutritional status in HIV infection

TitleEffect of dronabinol on nutritional status in HIV infection.
Author(s)Struwe M, Kaempfer SH, Geiger CJ, Pavia AT, Plasse TF, Shepard KV, Ries K, Evans TG.
Journal, Volume, IssueAnn Pharmacother. 1993 Jul-Aug;27(7-8):827-31.
Major outcome(s)Trends toward weight gain, improved appetite, decreased symptom stress
 
IndicationAppetite loss/weight loss;HIV/AIDSAbstract
MedicationDelta-9-THC

OBJECTIVE: To examine the effect of dronabinol (delta-9-tetrahydrocannabinol) on appetite and nutritional status in patients with symptomatic HIV infection and weight loss. DESIGN: Double-blind, randomized, placebo-controlled, crossover trial with two five-week treatment periods separated by a two-week washout period. Patients received dronabinol 5 mg twice daily before meals or placebo. SETTING: A university-based HIV/AIDS clinic and a large infectious disease private practice largely devoted to care of patients with HIV. PARTICIPANTS: Twelve HIV-infected patients who had had at least a 2.25-kg weight loss participated in the study. Five patients completed the protocol, and seven withdrew (two because of drug intolerance, two because of disease progression, two because of noncompliance, and one because of experimental antiretroviral therapy). MAIN OUTCOME MEASURES: Main outcome measures included caloric intake, weight, percent body fat, serum prealbumin, and symptom distress. RESULTS: During dronabinol treatment, subjects experienced increased percent body fat (one percent, p = 0.04); decreased symptom distress (p = 0.04); and trends toward weight gain (0.5 kg, p = 0.13), increased prealbumin (29.0 mg/L, p = 0.11), and improved appetite score (p = 0.14). CONCLUSIONS: In a selected group of HIV-infected patients with weight loss, short-term treatment with dronabinol may result in improvement in nutritional status and symptom distress.

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Dronabinol stimulates appetite and causes weight gain in HIV patients

TitleDronabinol stimulates appetite and causes weight gain in HIV patients.
Author(s)Plasse T, Conant M, Gorter R, Shepard KV
Journal, Volume, IssueInternational Conference on AIDS 1992;8(3):122 (abstract no. PuB 7442)
Major outcome(s)increase in appetite, trend toward weight gain
 
IndicationHIV/AIDS; Appetite loss/weight loss; DepressionAbstract
MedicationDelta-9-THC

OBJECTIVE: To test the effect of dronabinol (delta-9- tetrahydrocannabinol) on appetite and weight in symptomatic HIV patients (pts). METHODS: Forty pts with symptomatic HIV infection who were actively losing weight were entered into this dose ranging study of dronabinol (Marinol, Roxane Laboratories, Columbus OH). After a one week baseline period, pts were treated for 4 weeks; to be evaluable for efficacy, patients had to receive at least 3 weeks' medication. Pts were weighed and completed a questionnaire on physical and psychological symptoms weekly; they completed 100mm visual analog scales for hunger before each meal. Of 40 pts entered, 10 withdrew due to suspected adverse effects of study medication and 7 due to other causes. RESULTS: TABULAR DATA, SEE ABSTRACT VOLUME. CONCLUSIONS: In this open pilot study, dronabinol 2.5 mg bid was well tolerated and caused a significant increase in appetite, improvement of symptoms and a strong trend toward weight gain.

 


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Route(s)Oral
Dose(s)2.5 mg twice daily
Duration (days)28
Participants40 patients with AIDS
DesignControlled study
Type of publication 
Address of author(s)UNIMED Inc., Somerville, NJ., USA
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Dronabinol effects on weight in patients with HIV infection

TitleDronabinol effects on weight in patients with HIV infection.
Author(s)Gorter R, Seefried M, Volberding P
Journal, Volume, IssueAIDS 1992;6(1):127
Major outcome(s)weight gain
 
IndicationAppetite loss/weight loss;HIV/AIDSAbstract
MedicationDelta-9-THC

[Excerpt :]
Dronabinol effects on weight in patients with HIV infection
Weight loss is a major characteristic of symptomatic HIV infection and appears to be a prognostic factor in death from AIDS. Anecdotally, smoking marijuana has been noted to cause appetite stimulation in uninfected subjects. In addition, some AIDS patients who smoke marijuana have noted improved appetite and weight stabilization or gain. In controlled studies in normal volunteers and cancer patients, dronabinol [..] has been noted to cause weight gain and increase appetite. We therefore treated 12 symptomatic HIV-infected patients with dronabinol in an attempt to improve appetite and control weight loss. [..]

Patients were treated with dronabinol (Marinol, Roxane Laboratories, Columbus, Ohio, USA) at a starting dose of 2.5 mg orally three times daily. Doses, which were adjusted to minimize side-effects while stimulating appetite, ranged from 2.5 mg twice daily to 5 mg four times daily. Most patients were continuing treatment at the time of this analysis; the median duration of treatment was >= 12 weeks (range, > 4 to >20 weeks). [..]

All patients tolerated therapy well. They were able to adjust the medication dose to avoid unwanted THC side-effects, such as sedation and persistent euphoria. No patient discontinued therapy because of side-effects. Seven of the patients gained weight while on therapy and two others lost less than they had prior to therapy. Both patients who had previously received megestrol gained weight on dronabinol. The patient concurrently on megestrol lost weight, but slightly less rapidly than before starting dronabinol. While no formal measurements of body composition were performed, there was no clinical evidence that weight gain was due to fluid retention. [..]


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Route(s)Oral
Dose(s)2.5-5 mg twice to four times daily
Duration (days)28-140
Participants12 patients with AIDS
DesignOpen study
Type of publicationMedical journal
Address of author(s) 
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Recent clinical experience with dronabinol

TitleRecent clinical experience with dronabinol.
Author(s)Plasse TF, Gorter RW, Krasnow SH, Lane M, Shepard KV, Wadleigh RG
Journal, Volume, IssuePharmacol Biochem Behav. 1991 Nov;40(3):695-700.
Major outcome(s)Significant weight gain
 
IndicationAppetite loss/weight loss;HIV/AIDSAbstract
MedicationDelta-9-THC

Dronabinol, delta-9-tetrahydrocannabinol in sesame oil, has been used for several years as an antiemetic for patients receiving cancer chemotherapy. In combination studies with prochlorperazine, enhancement of efficacy, as measured by duration of episodes of nausea and vomiting and by severity of nausea, has been found. The incidence of psychotropic effects from dronabinol appears to be decreased by concomitant administration of prochlorperazine. In open pilot studies, dronabinol caused weight gain in seven of ten patients with symptomatic HIV infection. In both HIV and cancer patients, dronabinol improved appetite at a dose which was well tolerated for chronic administration.


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Route(s)Oral
Dose(s)THC 2x2.5 mg for 5 months
Duration (days) 
Participants10 patients with AIDS
DesignOpen study
Type of publicationMedical journal
Address of author(s)UNIMED, Inc., Somerville, NJ 08876.
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Dronabinol enhancement of appetite in cancer patients

TitleDronabinol enhancement of appetite in cancer patients.
Author(s)Wadleigh R, Spaulding GM, Lumbersky B, Zimmer M, Shepard K, Plasse T.
Journal, Volume, IssueProc Am Soc Oncology 1990; 9: 331.
Major outcome(s)Dronabinol stimulated mood and appetite
 
IndicationAppetite loss/weight loss;CancerAbstract
MedicationDelta-9-THC

Delta-9-tetrahydrocannabinol has previously been noted to enhance appetite in healthy individuals and in cancer patients. To further study this phenomenon, an open, dose- ranging study was carried out in patients with unresectable cancer. After a baseline observation period, patients were treated with dronabinol (delta-9-THC in sesame oil, Marinol, Roxane Labs, Columbus, OH) for up to six weeks at doses of 2.5 mg qd (N=8), 2.5 mg bid (N=9) or 5 mg qd (N=13); patient accrual and dose escalation are still continuing. Patients were weighed weekly; they recorded appetite before each meal and their overall mood once daily 0n 10cm visual analog scales (VAS). Five patients discontinued dronabinol because of adverse effects, although some may have been related to other medications; three discontinued because of progressive desease. Patients in all groups continued to lose weight, although the rate of weight loss decreased with therapy at all doses. Symptomatic improvement was noted in both mood and appetite, with 2.5 mg qd being a no- effect dose. For patients on study at least three weeks, the following was seen:
Group 2.5 mg qd: N=6; Mean VAS Mode=-1.5; change, Appetite: -5.4; Mean decrease in weight loss, ib/wk=1.3.
Group 2.5 mg bid: N=7; Mean VAS Mode=10.8; change, Appetite: 18; Mean decrease in weight loss, ib/wk=0.6.
Group 5 mg qd: N=9; Mean VAS Mode=1.2; change, Appetite: 8.9; Mean decrease in weight loss, ib/wk=1.7
In this open, dose-ranging study, dronabinol appeared to stimulate both mood and appetite at well tolerated doses.


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Route(s)Oral
Dose(s)2.5 mg twice - 5 mg four times daily
Duration (days)42
Participants30 cancer patients.
DesignOpen study
Type of publicationMeeting abstract
Address of author(s) 
Full text
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Dronabinol for supportive therapy in patients with malignant melanoma and liver metastases

Title[Dronabinol for supportive therapy in patients with malignant melanoma and liver metastases.] [Article in German]
Author(s)Zutt M, Hanssle H, Emmert S, Neumann C, Kretschmer L.
Journal, Volume, IssueHautarzt 2006;57(5):423-7.
Major outcome(s) A significant increase in appetite and decrease in nausea in most patients.
 
IndicationNausea/vomiting;Appetite loss/weight loss;Cancer;Cancer chemotherapyAbstract
MedicationDelta-9-THC

BACKGROUND: Loss of appetite and nausea can reduce the quality of life of patients with malignant melanoma and liver metastases. Often established antiemetic drugs fail to bring relief. Tetrahydrocannabinol (THC, Marinol (TM)), which is the active agent of Indian hemp, has been used successfully in this situation for other malignant tumors.PATIENTS AND METHODS: We treated 7 patients with hematogenous metastatic melanoma and liver metastases suffering from extensive loss of appetite and nausea supportively with dronabinol (Marinol((R))). All of these patients had previously received standard antiemetic therapy without adequate relief. Dronabinol is a synthetic Delta-tetrahydrocannabinol. The drug was administered in capsule form. We evaluated the palliative effects of dronabinol with a special patient evaluation form, which was filled out at the beginning of the therapy and again after 4 weeks.RESULTS: The majority of patients described a significant increase in appetite and decrease in nausea. These effects remained for some weeks, but then decreased as metastases progressed and the general condition worsened. All of the patients experienced slight to moderate dizziness, but it was not sufficiently troubling to cause interruption or termination of therapy.CONCLUSION: Loss of appetite and nausea due to liver metastases of malignant melanoma can be treated in individual cases supportively with Dronabinol.


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Route(s)Oral
Dose(s)variable
Duration (days) 
Participants7 patients with hematogenous metastatic melanoma
DesignOpen study
Type of publicationMedical journal
Address of author(s)Hautklinik und Poliklinik der Georg-August-Universitat Gottingen, Germany
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Dronabinol and prochlorperazine in combination

TitleDronabinol and prochlorperazine in combination for treatment of cancer chemotherapy-induced nausea and vomiting.
Author(s)Lane M, Vogel CL, Ferguson J, Krasnow S, Saiers JL, Hamm J
Journal, Volume, IssueJournal of Pain and Symptom Management 1991;6:352-359
Major outcome(s)prochlorperazine better than THC, both drugs combined better than both alone
 
IndicationNausea/vomiting;Cancer;Cancer chemotherapyAbstract
MedicationDelta-9-THC

Dronabinol (Marinol, Roxane Laboratories, Columbus, OH) and prochlorperazine were tested alone and in combination in a randomized, double-blind, parallel group, multicenter study. Patients were randomized to receive either 1) dronabinol 10 mg every 6 hr plus placebo; 2) placebo plus prochlorperazine 10 mg every 6 hr; or 3) dronabinol and prochlorperazine, each 10 mg every 6 hr. Antiemetic treatment was begun 24 hr prior to and continued for 24 hr after the last dose of chemotherapy; all was given orally. Only 29% of patients in group 3 versus 47% in group 1 and 60% in group 2 experienced nausea after chemotherapy. In addition, the median duration per episode and severity of nausea were significantly less with combination therapy. Vomiting occurred after chemotherapy in 41%, 55%, and 35% of patients in groups 1, 2, and 3, respectively. The median duration per episode of vomiting was 1 min in group 3 versus two in group 1 and four in group 2. Side effects, primarily CNS, were more common in group 1 than in group 2; addition of prochlorperazine to dronabinol appeared to decrease the frequency of dysphoric effects seen with the latter agent. The combination was significantly more effective than was either single agent in controlling chemotherapy-induced nausea and vomiting.


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Route(s)Oral
Dose(s) 
Duration (days)10 mg every 6 hr
Participants67 patients on various cancer chemotherapie
DesignControlled study
Type of publication 
Address of author(s) 
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Efficacy of dronabinol alone and in combination

TitleEfficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone for delayed chemotherapy-induced nausea and vomiting.
Author(s)Meiri E, Jhangiani H, Vredenburgh JJ, Barbato LM, Carter FJ, Yang HM, Baranowski V.
Journal, Volume, IssueCurr Med Res Opin 2007;23(3):533-43.
Major outcome(s)Dronabinol was as effective as ondansetron in reducing nausea and vomiting. Combination therapy was not more effective.
 
IndicationNausea/vomiting;Cancer;Cancer chemotherapyAbstract
MedicationDelta-9-THC

OBJECTIVE: To compare the efficacy and tolerability of dronabinol, ondansetron, or the combination for delayed chemotherapy-induced nausea and vomiting (CINV) in a 5-day, double-blind, placebo-controlled study. RESEARCH DESIGN AND METHODS: Patients receiving moderately to highly emetogenic chemotherapy received dexamethasone (20 mg PO), ondansetron (16 mg IV) and either placebo or dronabinol (2.5 mg) prechemotherapy on day 1. Patients randomized to active treatment (dronabinol and/or ondansetron) also received dronabinol (2.5 mg) after chemotherapy on day 1. On day 2, fixed doses of placebo, dronabinol (10 mg), ondansetron (16 mg), or combination therapy were administered. On days 3-5, patients received placebo, flexible doses of dronabinol (10-20 mg), ondansetron (8-16 mg), or dronabinol and ondansetron (10-20 mg dronabinol, 8-16 mg ondansetron). MAIN OUTCOME MEASURES: Total response (TR = nausea intensity <5 mm on visual analog scale, no vomiting/retching, no rescue antiemetic), nausea (occurrence and intensity) and vomiting/retching episodes. RESULTS: Sixty-four patients were randomized; 61 analyzed for efficacy. TR was similar with dronabinol (54%), ondansetron (58%), and combination therapy (47%) versus placebo (20%). Nausea absence was significantly greater in active treatment groups (dronabinol, 71%; ondansetron, 64%; combination therapy, 53%) versus placebo (15%; p < 0.05 vs. placebo for all). Nausea intensity and vomiting/retching were lowest in patients treated with dronabinol. Active treatments were well tolerated. The low number of patients due to slow enrollment limits the interpretation of these data. CONCLUSIONS: Dronabinol or ondansetron was similarly effective for the treatment of CINV. Combination therapy with dronabinol and ondansetron was not more effective than either agent alone. Active treatments were well tolerated.


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Route(s)Oral
Dose(s)10-20 mg
Duration (days)5
Participants64 patients undergoing chemotherapy
DesignControlled study
Type of publicationMedical journal
Address of author(s)Bethesda Memorial Hospital, Comprehensive Cancer Care Center, Boynton Beach, FL 33435-7995, USA. mdeyal@hotmail.com
Full text

Dronabinol and marijuana in HIV-positive marijuana smokers: caloric intake, mood, and sleep


Author(s)

HANEY Margaret  ; GUNDERSON Erik W.  ; RABKIN Judith  ; HART Carl L.  ; VOSBURG Suzanne K.  ; COMER Sandra D.  ; FOLTIN Richard W.  ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

Division on Substance Abuse, New York State Psychiatric Institute, and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, ETATS-UNIS
Department of Psychology, Columbia University, New York, NY, ETATS-UNIS

Abstract

Objectives: Individuals with HIV constitute the largest group using cannabinoids for medicinal reasons; yet, no studies have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol maintenance in HIV-positive marijuana smokers. This placebo-controlled within-subjects study evaluated marijuana and dronabinol across a range of behaviors: eating topography, mood, cognitive performance, physiologic measures, and sleep. Methods: HIV-positive marijuana smokers (n = 10) completed 2 16-day inpatient phases. Each dronabinol (5 and 10 mg) and marijuana (2.0% and 3.9% Δ9-tetrahydrocannabinol [THC]) dose was administered 4 times daily for 4 days, but only 1 drug was active per day, thereby maintaining double-blind dosing. Four days of placebo washout separated each active cannabinoid condition. Results: As compared with placebo, marijuana and dronabinol dose dependently increased daily caloric intake and body weight in HIV-positive marijuana smokers. All cannabinoid conditions produced significant intoxication, except for low-dose dronabinol (5 mg); the intoxication was rated positively (eg, "good drug effect") with little evidence of discomfort and no impairment of cognitive performance. Effects of marijuana and dronabinol were comparable, except that only marijuana (3.9% THC) improved ratings of sleep. Conclusions: These data suggest that for HIV-positive marijuana smokers, both dronabinol (at doses 8 times current recommendations) and marijuana were well tolerated and produced substantial and comparable increases in food intake.

Journal Title

Journal of acquired immune deficiency syndromes    ISSN  1525-4135 

Source / Source

2007, vol. 45, no5, pp. 545-554 [10 page(s) (article)] (58 ref.)

Publisher

Lippincott Williams & Wilkins, Hagerstown, MD, ETATS-UNIS  (1999) (Revue)
LocationINIST-CNRS, Cote INIST : 21576, 35400015003578.0090

 


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Dronabinol and retinal hemodynamics in humans

TitleDronabinol and retinal hemodynamics in humans.
Author(s)Plange N, Arend KO, Kaup M, Doehmen B, Adams H, Hendricks S, Cordes A, Huth J, Sponsel WE, Remky A.
Journal, Volume, IssueAm J Ophthalmol. 2007 Jan;143(1):173-4.
Major outcome(s)THC reduced intraoculat pressure and improved blood circulation in the retina.
 
IndicationGlaucomaAbstract
MedicationDelta-9-THC

PURPOSE: To investigate the effects of oral cannabinoids on retinal hemodynamics assessed by video fluorescein angiography in healthy subjects. DESIGN: Interventional study. METHODS: In a self-experiment, the cannabinoid dronabinol (delta-9-tetrahydrocannabinol [THC]) was administered orally to eight healthy medical doctors (7.5 mg Marinol; Unimed Pharmaceuticals, Chicago, Illinois, USA). At baseline and two hours after dronabinol intake, intraocular pressure (IOP) was measured and retinal hemodynamics were assessed by fluorescein angiography. The retinal arteriovenous passage time was determined on the basis of dye dilution curves by means of digital image analysis in a masked fashion. RESULTS: Dronabinol resulted in a significant IOP reduction from 13.2 +/- 1.9 mm Hg to 11.8 +/- 2.0 mm Hg (P = .038). The retinal arteriovenous passage time decreased from 1.77 +/- 0.35 seconds to 1.57 +/- 0.31 seconds (P = .028). Systemic blood pressure and heart rate were not statistically significantly altered. CONCLUSIONS: Cannabinoids, already known for their ability to reduce IOP, may result in increased retinal hemodynamics. This may be beneficial in ocular circulatory disorders, including glaucoma.


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Route(s)Oral
Dose(s)7.5 mg
Duration (days)1
Participants8 healthy subjects
DesignOpen study
Type of publicationMedical journal
Address of author(s)RWTH Aachen University, Department of Ophthalmology, Aachen, Germany.
Full text

Dronabinol reduces signs and symptoms of idiopathic intracranial hypertension

TitleDronabinol reduces signs and symptoms of idiopathic intracranial hypertension: a case report.
Author(s)Raby WN, Modica PA, Wolintz RJ, Murtaugh K.
Journal, Volume, IssueJ Ocul Pharmacol Ther. 2006 Feb;22(1):68-75.
Major outcome(s)Improvement of signs and symptoms of the disease
 
Indication Abstract
MedicationCannabis;Delta-9-THC

A case is presented in which a woman diagnosed with a longstanding history of idiopathic intracranial hypertension reported improvement of frontal headaches, photophobia, transient blindness, enlarged blind spots, and tinnitus after smoking marijuana. All these symptoms and signs were associated with increased intracranial pressure (220-425 mm of water). Treatment with dronabinol at a dose of 10 mg twice a day, then reduced to 5 mg twice a day, relieved all of her symptoms. Previously noted papilledema and enlargement of blind spots also resolved, and this, in the absence of psychoactive effect or weight gain


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Route(s)Inhalation;Oral
Dose(s)2 x 10 mg THC
Duration (days) 
Participants1 patient with idiopathic intracranial hypertension
DesignUncontrolled case report
Type of publicationMedical journal
Address of author(s)New York State Psychiatric Institute, Substance Abuse Division, The S.T.A.R.S. Clinic, New York, NY.
Full text

Nausea relieved by tetrahydrocannabinol (dronabinol

TitleIntractable nausea and vomiting due to gastrointestinal mucosal metastases relieved by tetrahydrocannabinol (dronabinol).
Author(s)Gonzalez-Rosales F, Walsh D
Journal, Volume, IssueJournal of Pain and Symptom Management 1997;14(5):311-314
Major outcome(s)patients was treated with several antiemetic drugs, but it was not until dronabinol was added that the nausea and vomiting stopped
 
IndicationNausea/vomiting;Cancer;Cancer chemotherapyAbstract
MedicationDelta-9-THC

Four years following resection of a Clark's level IV malignant melanoma, a 50-year-old man developed widespred metastatic disease involving the liver, bones, brain, gastrointestinal mucosa, and lungs. One week after whole brain radiation therapy, he was admitted to the hospital for nausea, vomiting, and pain. He was treated with several antiemetic drugs, but it was not until dronabinol was added that the nausea and vomiting stopped. Dronabinol was an effective antiemetic used in combination with prochlorperazine in nausea and vomiting unresponsive to conventional antiemetics.


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Route(s)Oral
Dose(s) 
Duration (days) 
Participants1 patient with nausea and vomiting after whole brain radiati
DesignUncontrolled case report
Type of publication 
Address of author(s)Department of Hematology/Oncology, Cleveland Clinic Cancer Center, Cleveland Clinic Foundation, Ohio 44195, USA
Full text 

Dronabinol in patients with intractable pruritus secondary to cholestatic liver disease

TitlePreliminary observation with dronabinol in patients with intractable pruritus secondary to cholestatic liver disease.
Author(s)Neff GW, O'Brien CB, Reddy KR, Bergasa NV, Regev A, Molina E, Amaro R, Rodriguez MJ, Chase V, Jeffers L, Schiff E.
Journal, Volume, IssueAm J Gastroenterol 2002;97(8):2117-9
Major outcome(s)THC signficantly reduced intractable cholestatic related pruritus
 
Indication Abstract
MedicationDelta-9-THC

Pruritus due to cholestatic liver disease can be particularly difficult to
manage and frequently is intractable to a variety of medical therapies. The aim
of our study is to evaluate the efficacy of delta-9-tetrahydrocannabinol
(delta-9-THC) for intractable cholestatic related pruritus (ICRP) that has
failed conventional (and unconventional) remedies. Three patients were evaluated
for plasmapheresis because of ICRP. All 3 patients had previously been
extensively treated with standard therapies for ICRP including: diphenhydramine,
chlorpheniramine, cholestyramine, rifampicin, phenobarbital, doxepin,
naltrexone, UV therapy, and topical lotions. Even multiple courses of
plasmapheresis were performed without any benefit for the intractable pruritus.
All patients reported significant decreases in their quality of life, including
lack of sleep, depression, inability to work, and suicidal ideations. All
patients were started on 5 mg of delta-9-THC (Marinol) at bedtime. All 3
patients reported a decrease in pruritus, marked improvement in sleep, and
eventually were able to return to work. Resolution of depression occurred in two
of three. Side effects related to the drug include one patient experiencing a
disturbance in coordination. Marinol dosage was decreased to 2.5 mg in this
patient with resolution of symptoms. The duration of antipruritic effect is
approximately 4-6 hrs in all three patients suggesting the need for more
frequent dosing. Delta-9-tetrahydrocannabinol may be an effective alternative in
patients with intractable cholestatic pruritus.


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Treatment of spasticity in spinal cord injury with dronabinol

TitleTreatment of spasticity in spinal cord injury with dronabinol, a tetrahydrocannabinol derivative.
Author(s)Kogel RW, Johnson PB, Chintam R, Robinson CJ, Nemchausky BA.
Journal, Volume, IssueAm J Ther. 1995 Oct;2(10):799-805.
Major outcome(s)Spasticity was markedly improved in 2 o 5 patients
 
IndicationSpasticity;Spinal cord injuryAbstract
MedicationDelta-9-THC

Spinal-cord-injured patients and the medical literature have increasingly reported anecdotes regarding tetrahydrocannabinol (THC)-induced spasmolysis. These reports motivated this trial of dronabinol, a THC derivative, for the treatment of spasticity in the spinal-cord-injured population. Five male quadriplegic patients were given oral dronabinol in escalating doses from 5 mg BID to 20 mg TID in addition to their current, but ineffective, spasmolytic regime. The pendulum drop test was used to quantify spasticity (stiffness) in the knees. The Weschler Memory Scale (WMS), Profile of Mood States (POMS), and personal interviews were administered by the clinical psychologist to evaluate any changes in the subjects' cognition and/or emotional states. Spasticity was markedly improved in two of the five subjects, unchanged in a third, fluctuated in a fourth and made progressively worse in a fifth. The WMS revealed improvement in memory skills of two subjects and no change in the other. Psychological interviews and the POMS indicated decreased vigor in all subject, but otherwise demonstrated highly individualized emotional changes as indicated by increases and/or decreases in the dysphoric mood scales.


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Route(s)Oral
Dose(s)2 x 5 mg until 3 x 20 mg
Duration (days) 
Participants5 male quadriplegic patients
DesignOpen study
Type of publicationMedical journal
Address of author(s)Medical College of Georgia, Augusta, GA, USA.
Full text

Cannabinoid Activator Mellows Out Colon

By Jeff Minerd, Contributing Writer, MedPage Today
Published: October 31, 2006
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco .

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Action Points  
  • Advise patients that larger clinical trials would be necessary before cannabinoid activators could be used widely for conditions of the lower colon.
  • This report is based on an abstract presented at a meeting. These data and conclusions should be considered preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
LAS VEGAS, Oct. 31 -- Drugs that activate cannabinoid receptors in the colon might help treat lower GI conditions such as diarrhea or certain types of fecal incontinence, according to a proof-of-concept study presented here.

The study found that Marinol (dronabinol) significantly relaxed the colon in healthy volunteers who had consumed a 1,000-calorie chocolate milkshake, reported Tuba Esfandyari, M.D., of the Mayo Clinic in Rochester, Minn., at the American College of Gastroenterology meeting here.

The study is the first to demonstrate that the drug, a synthetic version of the natural compound delta-9-THC found in the marijuana plant, may also have beneficial effects in the lower colon, said co-author Michael Camilleri, M.D., also of the Mayo Clinic. Marinol is approved to treat nausea, vomiting, and lack of appetite during chemotherapy.

In the double-blind, parallel-group study, 52 volunteers were randomly assigned to a single dose of 7.5 mg of Marinol or placebo. Thirty of the volunteers were women and 22 were men. Their average age was about 35.

Before taking Marinol, baseline measurements of colonic contraction and sensation were taken. These measurements were repeated one hour after taking the medication. Finally, the measurements were taken once again an hour after participants drank the milkshake.

Compared with placebo, the drug was associated with significant inhibition of postprandial colonic contractions (P=0.048) as well as a non-significant effect on fasting colonic contractions (P=0.096), the researchers reported.

The effect on colonic contraction was more pronounced in women than men, the researchers said, although data on the gender difference was not reported.

The drug also had an overall significant relaxing effect on the colon (P=0.045), the study found.

The drug did not appear to have a significant effect on participants' feelings of abdominal pain or discomfort after ingesting the milkshake, the study authors reported.

Nevertheless, the results suggest that "the potential for cannabinoids to modulate colonic motor function in disease deserves further study," the investigators concluded.

 

More specifically, the drug's ability to inhibit colonic contraction after a meal might help treat certain types of fecal incontinence that are not based on abnormal sphincter function but on unusually strong colonic contractions, Dr. Camilleri said.

The drug, or others like it, might also be useful for treating the diarrhea associated with irritable bowel syndrome, he said.

Marinol is a non-selective cannabinoid activator, but the study suggests selective cannabinoid activators might have the same effects on the colon, Dr. Camilleri said.

Selective cannabinoid activators would likely not have the psychoactive side effects associated with Marinol or other non-selective cannabinoid activators. However, Marinol was the only drug available for study in humans, Dr. Camilleri said.

Marinol is made by Slovay Pharmaceuticals of Marietta, Ga. The company did not fund this study.


Primary source: American College of Gastroenterology
Source reference:
Tuba Esfandyari et al. "A non-selective cannabinoid agonist relaxes the colon and reduces post-prandial colonic contraction in humans." Abstract number 25. Presented at the American College of Gastroenterology Annual Meeting, Las Vegas, Nevada, October 23-25, 2006.
 
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Dronabinol and marijuana in HIV-positive marijuana smokers. Caloric intake, mood, and sleep

Haney M, Gunderson EW, Rabkin J, Hart CL, Vosburg SK, Comer SD, Foltin RW

Division on Substance Abuse, New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY 10032, USA. mh235@columbia.edu


OBJECTIVES: Individuals with HIV constitute the largest group using cannabinoids for medicinal reasons; yet, no studies have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol maintenance in HIV-positive marijuana smokers. This placebo-controlled within-subjects study evaluated marijuana and dronabinol across a range of behaviors: eating topography, mood, cognitive performance, physiologic measures, and sleep. METHODS: HIV-positive marijuana smokers (n = 10) completed 2 16-day inpatient phases. Each dronabinol (5 and 10 mg) and marijuana (2.0% and 3.9% Delta9-tetrahydrocannabinol [THC]) dose was administered 4 times daily for 4 days, but only 1 drug was active per day, thereby maintaining double-blind dosing. Four days of placebo washout separated each active cannabinoid condition. RESULTS: As compared with placebo, marijuana and dronabinol dose dependently increased daily caloric intake and body weight in HIV-positive marijuana smokers. All cannabinoid conditions produced significant intoxication, except for low-dose dronabinol (5 mg); the intoxication was rated positively (eg, "good drug effect") with little evidence of discomfort and no impairment of cognitive performance. Effects of marijuana and dronabinol were comparable, except that only marijuana (3.9% THC) improved ratings of sleep. CONCLUSIONS: These data suggest that for HIV-positive marijuana smokers, both dronabinol (at doses 8 times current recommendations) and marijuana were well tolerated and produced substantial and comparable increases in food intake.

Published 31 August 2007 in J Acquir Immune Defic Syndr, 45(5): 545-54.
Full-text of this article is available online (may require subscription).

 

 

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Improvement in Refractory Obsessive Compulsive Disorder With Dronabinol

Am J Psychiatry 165:536-537, April 2008

 © 2008 American Psychiatric Association

 

Letter to the Editor

FRANK SCHINDLER, M.D., ION ANGHELESCU, M.D., Ph.D., FRANCESCA REGEN, M.D., and MARIA JOCKERS-SCHERUBL, M.D., Ph.D.
Berlin, Germany

To the Editor: It has been reported that 40%–60% of patients with obsessive-compulsive disorder (OCD) do not respond to first-line treatment. Treatment options for these patients include switching to another agent or augmentation. We report on two patients with treatment-resistant OCD and comorbid axis I disorders who responded to an augmentation with the cannabinoid dronabinol.

 

"Mrs. L" was a 38-year-old woman who was admitted with recurrent major depression and OCD (Yale-Brown Obsessive Compulsive Scale score: 20) after outpatient treatment with paroxetine (60 mg) for 8 months and cognitive behavioral therapy (CBT) were not efficacious. Switching to clomipramine (300 mg) resulted in partial response after 12 weeks of treatment. Based on the patient’s report that smoking marijuana usually relieved her symptoms, an augmentation with dronabinol (2.5%; 10 mg t.i.d.) was started. The prior medication was continued. While undergoing treatment with dronabinol (2.5%), the patient’s OCD symptoms decreased significantly within 10 days (Yale-Brown Obsessive Compulsive Scale score: 10).

"Mr. K" was a 36-year-old man with schizophrenia and OCD who was admitted for deterioration of psychotic and obsessive symptoms (Yale-Brown Obsessive Compulsive Scale score: 23). During his course of illness, Mr. K had been treated with antipsychotics (including haloperidol, olanzapine, risperidone, quetiapine, and aripiprazole), both in monotherapy and in combination with selective serotonin reuptake inhibitors. His OCD symptoms in particular remained predominately treatment resistant. Treatment with clozapine (400 mg), which he had already received for more than 1 year (in combination with paroxetine [60 mg] for 13 weeks) resulted only in partial response of his psychotic and OCD symptoms. Switching paroxetine to clomipramine (for another 10 weeks), followed by an additional course of 18 electroconvulsive therapy treatments (right unilateral high dose), did not improve the patient’s psychotic or OCD symptoms significantly. After the addition of dronabinol to ongoing treatment with clomipramine (150 mg) and clozapine (400 mg), a significant reduction of OCD symptoms was observed within 2 weeks (Yale-Brown Obsessive Compulsive Scale score: 15). In order to prevent psychotic deterioration, dronabinol (2.5%) was carefully increased to 10 mg b.i.d.

Apart from anticholinergic symptoms that preceded the addition of dronabinol (patient 1: dry mouth, constipation; patient 2: constipation, hypotension), both patients reported no side effects. In particular, there was no deterioration of psychotic or mood disorder symptoms.

 

Based on data from case reports and small clinical trials suggesting that cannabinoids can reduce symptoms of tic disorder and on findings from genetic studies linking tic disorder with OCD , we hypothesized that cannabinoids might also reduce OCD symptoms. Moreover, there is evidence suggesting that besides serotonergic and dopaminergic systems, glutamatergic hyperactivity is involved in the pathophysiology of OCD. This view is supported by data suggesting the efficacy of glutamate modulating drugs, such as topiramate, memantine, riluzole, or N-acetylcysteine, in the treatment of OCD . It has been reported that cannabinoids inhibit glutamate release in the CNS. Additionally, cannabinoid type 1 (CB1) receptors are distributed abundantly in the striatum , a brain region frequently associated with OCD. Hence, it can be speculated that the anti-obsessive effect observed in our patients may have been a consequence of the glutamate modulation of the cannabinoid dronabinol. Since it is well known that cannabinoids may trigger psychotic symptoms in patients with schizophrenia, caution is warranted when prescribing for patients with a history of the disorder.

Footnotes

The authors report no competing interests.

This letter (doi: 10.1176/appi.ajp.2007.07061016) was accepted for publication in September 2007.

References

 

  1. Kaplan A, Hollander E: A review of pharmacologic treatments for obsessive-compulsive disorder. Psychiatr Serv 2003; 54:1111–1118[Abstract/Free Full Text]
  2. Müller-Vahl KR, Schneider U, Prevedel H, Theloe K, Kolbe H, Daldrup T, Emrich HM: Delta-9-tetrahydrocannabinol (THC) is effective in the treatment of tics in Tourette syndrome: a 6-week randomized trial. J Clin Psychiatry 2003; 64:459–465[Medline]
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  4. Arnold PD, Sicard T, Burroughs E, Richter MA, Kennedy JL: Glutamate-transporter gene SLC1A1 associated with obsessive-compulsive disorder. Arch Gen Psychiatry 2006; 63:769–776[Abstract/Free Full Text]
  5. Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S: Glutamatergic dysfunction in OCD. Neuropsychopharmacology 2005; 30:1735–1740[CrossRef][Medline]
  6. Pittenger C, Krystal JH, Coric V: Glutamate-modulating drugs as novel pharmacotherapeutic agents in the treatment of obsessive-compulsive disorder. NeuroRx 2006; 3:69–81[CrossRef][Medline]
  7. Fujiwara M, Egashira N: New perspectives in the studies on endocannabinoid and cannabis: abnormal behaviors associate with CB1-receptor and development of therapeutic application. J Pharmacol Sci 2004; 96:363–366
  8. Pacher P, Bátkai S, Kunos G: The endocannabinoid system as an emerging target of pharmacotherapy. Pharmacol Rev 2006; 58:389–462[Abstract/Free Full Text]


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Effects of {Delta}9-tetrahydrocannabinol on reward and anxiety in rats exposed to chronic unpredictable stress

Fokos S, Panagis G

 J Psychopharmacol 2009 Apr 30.

AbstractAlthough cannabis derivatives produce clear subjective motivational responses in humans leading to drug-seeking behaviour, the reinforcing attributes of these subjective effects are difficult to define in experimental animals. The aim of this study was to examine how exposure to chronic unpredictable stress (CUS) will affect reward function and anxiety after acute administration of Delta(9)-tetrahydrocannabinol (Delta(9)-THC) in rats. Male rats were exposed to either 10 days of CUS or no stressor. Alterations in brain reward function were assessed with the intracranial self-stimulation (ICSS) paradigm, and anxiety responses were measured with the elevated plus maze. CUS did not affect baseline brain stimulation reward thresholds. Delta(9)-THC did not exhibit reinforcing actions in the ICSS paradigm neither in nonstressed nor in stressed animals. More importantly, in nonstressed animals, both the low and the high dose of Delta(9)-THC exerted anxiolytic-like effects. In stressed animals, however, only the high dose of THC induced an anxiolytic-like response, whereas the low dose induced anxiogenic effects. The present results provide clear evidence for an anxiolytic effect of Delta(9)-THC both in stressed and in nonstressed animals, and indicate that environmental conditions, such as stressful experiences, do not alter the behavioural effects of Delta(9)-THC in the ICSS paradigm.

 

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Synthetic delta-9-tetrahydrocannabinol (dronabinol) can improve the symptoms of schizophrenia.

Schwarcz G, Karajgi B, McCarthy R

We are reporting improvement of symptoms of schizophrenia in a small group of patients who received the cannabinoid agonist dronabinol (synthetic Delta-9-tetrahydrocannabinol). Before this report, cannabinoids had usually been associated with worsening of psychotic symptoms. In a heuristic, compassionate use study, we found that 4 of 6 treatment-refractory patients with severe chronic schizophrenia but who had a self-reported history of improving with marijuana abuse improved with dronabinol. This improvement seems to have been a reduction of core psychotic symptoms in 3 of the 4 responders and not just nonspecific calming. There were no clinically significant adverse effects. These results complement the recent finding that the cannabinoid blocker rimonabant does not improve schizophrenic symptoms and suggest that the role of cannabinoids in psychosis may be more complex than previously thought. They open a possible new role for cannabinoids in the treatment of schizophrenia.

 

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Current Status of Cannabis Treatment of Multiple Sclerosis with an Illustrative Case Presentation of a Patient with MS, Complex Vocal Tics, Paroxysmal Dystonia, and Marijuana Dependence Treated with Dronabinol

Deutsch SI, Rosse RB, Connor JM, Burket JA, Murphy ME, Fox FJ

Pain, spasticity, tremor, spasms, poor sleep quality, and bladder and bowel dysfunction, among other symptoms, contribute significantly to the disability and impaired quality of life of many patients with multiple sclerosis (MS). Motor symptoms referable to the basal ganglia, especially paroxysmal dystonia, occur rarely and contribute to the experience of distress. A substantial percentage of patients with MS report subjective benefit from what is often illicit abuse of extracts of the Cannabis sativa plant; the main cannabinoids include delta-9-tetrahydrocannabinol (delta9-THC) and cannabidiol. Clinical trials of cannabis plant extracts and synthetic delta9-THC provide support for therapeutic benefit on at least some patient self-report measures. An illustrative case is presented of a 52-year-old woman with MS, paroxysmal dystonia, complex vocal tics, and marijuana dependence. The patient was started on an empirical trial of dronabinol, an encapsulated form of synthetic delta9-THC that is usually prescribed as an adjunctive medication for patients undergoing cancer chemotherapy. The patient reported a dramatic reduction of craving and illicit use; she did not experience the "high" on the prescribed medication. She also reported an improvement in the quality of her sleep with diminished awakenings during the night, decreased vocalizations, and the tension associated with their emission, decreased anxiety and a decreased frequency of paroxysmal dystonia.

 

 

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GENERIC NAME: DRONABINOL - ORAL (dro-NAB-in-all)
BRAND NAME(S): Marinol

 

This medication is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients infected with HIV (the virus that causes AIDS). Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana.

 USES

HOW TO USE: Take this medication by mouth as directed by your doctor. Dosage is based on your medical condition and response to therapy. If you are taking this medication to control nausea and vomiting, your dose is also based on your body size.Do not increase your dose or take this medication more often without your doctor's approval. Your risk of serious side effects may be increased. If you are taking dronabinol to stimulate appetite (for AIDS patients), do not take more than 20 milligrams per day unless approved by your doctor.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as irritability, trouble sleeping, restlessness, hot flashes, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Although it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.Inform your doctor if your symptoms worsen or do not improve.

 SIDE EFFECTS

Dizziness, drowsiness, confusion, feeling "high", an exaggerated sense of well-being, lightheadedness, headache, red eyes, dry mouth, nausea, vomiting, stomach pain, clumsiness, or unsteadiness may occur, especially during the first several days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, flushing of the face, fast/pounding heartbeat, mental/mood changes (e.g., difficulty concentrating, memory loss, hallucinations, abnormal thoughts, paranoia, depression, nervousness), slurred speech, ringing in the ears, vision changes, fainting.It is important that you take this medication under the supervision of a responsible adult because mental, mood, or behavior changes may occur. If you experience any such effects, remain calm and try not to panic. Tell your doctor immediately. Do not take any more dronabinol until after you consult with your doctor.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana or sesame oil; or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood conditions (e.g., mania, depression, schizophrenia), seizure disorder.This drug may make you dizzy or drowsy or affect your judgment. Do not engage in activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects you and until you are sure you can perform such activities safely. Alcohol can worsen these side effects. Avoid alcoholic beverages.To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.Caution is advised when using this drug in children because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.This medication is not recommended for use during pregnancy because of possible unborn baby/infant harm reported with marijuana exposure (dronabinol contains the active substance found in marijuana). Consult your doctor for more details.This drug passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

 DRUG INTERACTIONS

 Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: disulfiram.Tell your doctor or pharmacist if you take recreational or "street" drugs (e.g., "uppers" such as amphetamines, cocaine) because they may cause serious interactions with this medication.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine, phenobarbital), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), antidepressant drugs (e.g., amitriptyline, fluoxetine), tranquilizers.Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness or make your heart beat faster. Ask your pharmacist about the safe use of these products.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe drowsiness, fast heartbeat, panic reaction, seizures.

NOTES: Do not share this medication with others. It is against the law.Keep all medical appointments so your doctor can monitor your weight and response to treatment and check for side effects.

 MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container in a cool, dry place between 46-59 degrees F (8-15 degrees C) away from light and moisture. This medication may be refrigerated, but do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

 

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