Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.
Frances R. Levin, John J Mariani, Daniel J Brooks, Martina Pavlicova, Wendy Cheng, Edward V. Nunes
Drug and Alcohol Dependence July 1, 2011 DOI: 10.1016/j.drugalcdep.2010.12.010 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 156 |
| Population | Cannabis-dependent adults |
| Interventions | Dronabinol motivational enhancement and relapse prevention therapy |
| Dose | 20 mg twice a day |
| Duration | 12-week trial with 1-week placebo lead-in; doses maintained until end of week 8, then tapered over 2 weeks |
| Measures | timeline follow back method |
| Topics | Addiction Cannabis |
| Key findings | Dronabinol did not significantly improve abstinence rates compared with placebo (17.7% vs 15.6% achieving two weeks of abstinence), and both groups reduced marijuana use similarly. However, dronabinol was associated with significantly higher treatment retention (77% vs 61%) and significantly lower withdrawal symptoms. The authors conclude that dronabinol showed promise and was well-tolerated, suggesting future trials of higher doses or combination strategies. |
Abstract
Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow back method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P=.02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P=.02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions.
Comparable studies
Other randomized controlled trials on cannabis for addiction, most cited first.
Citations in the library
Cited by 12
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- The Neurocircuitry of Substance Use Disorder, Treatment, and Change: A Resource for Clinical Psychiatrists American Journal of Psychiatry October 9, 2024
- The use of psychoactive substances in the treatment of mental disorders Alcoholism and Drug Addiction August 31, 2022
- Cannabis and cannabinoids for the treatment of mental and substance use disorders and symptoms: A systematic review and meta-analysis of experimental and observational studies. Psychiatry Research August 1, 2026
- Relationships between cannabis use and mental disorders: assessing the coherence of evidence from studies with different methodologies. The Lancet Psychiatry July 1, 2026
and 7 more in the library
Cites 3
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- Nefazodone decreases anxiety during marijuana withdrawal in humans. Psychopharmacology January 2003
- Effects of oral THC maintenance on smoked marijuana self-administration. Drug and Alcohol Dependence August 1, 2002