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Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.
Open accessAbstract
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.
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“although the CB1 agonist dronabinol has reduced cannabis withdrawal symptoms and increased retention in treatment when compared with placebo in early studies 51”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [51]
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Metadata
- Authors
- Levin, F. R., Mariani, J. J., Brooks, D. J., Pavlicova, M., Cheng, W., & Nunes, E. V.
- Affiliations
- New York State Psychiatric Institute (US)
- Corresponding author
- Levin, Frances R.
- Venue
- Drug and Alcohol Dependence
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 116
- Issue
- 1-3
- Pages
- 142-150
- ISSN
- 0376-8716 (ISSN-L)
- PMC
- PMC3154755
- OpenAlex
- W1979308736
- Cited by
- 232
- References
- 64
- Citations by year
- 2026: 12 · 2025: 7 · 2024: 17 · 2023: 15 · 2022: 25 · 2021: 15 · 2020: 13 · 2019: 12 · 2018: 23 · 2017: 11 · 2016: 14 · 2015: 19 · 2014: 20 · 2013: 9 · 2012: 17
- FWCI
- 11.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Drug and Alcohol Dependence (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- U.S. Public Health Service (K02 000465)
- National Institute on Drug Abuse (K24DA022412, P50DA009236, K24DA029647, T32DA007294)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
- Keywords
- dronabinol, cannabis use disorder, delta-9-tetrahydrocannabinol, treatment retention, withdrawal symptoms, motivational enhancement therapy, abstinence, drug safety and tolerability
- MeSH terms
- Adult, Cannabinoids, Marijuana Abuse, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Marijuana Smoking, Middle Aged, Placebos, Psychotherapy, Psychotropic Drugs, Substance Withdrawal Syndrome, Dronabinol, Behavior, Addictive
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