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

Levin, Frances R.; Mariani, John J.; Brooks, Daniel J.; Pavlicova, Martina; Cheng, Wendy; Nunes, Edward V.

doi:10.1016/j.drugalcdep.2010.12.010

Cited by 233Cannabis and Cannabinoid ResearchSubstance Abuse Treatment and OutcomesSmoking Behavior and Cessation

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

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Levin, Frances R., Mariani, John J., Brooks, Daniel J., Pavlicova, Martina, Cheng, Wendy, Nunes, Edward V.·2011·Drug and Alcohol Dependence

DOI 10.1016/j.drugalcdep.2010.12.010PMC PMC3154755

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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.

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Dronabinol reduced cannabis withdrawal symptoms and increased retention in treatment compared with placebo in early studies.
“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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Plasma Cannabinoid Concentrations During Dronabinol Pharmacotherapy for Cannabis Dependence
Milman, G., Bergamaschi, M. M., Lee, D., Mendu, D. R., Barnes, A. J., Vandrey, R. G., & Huestis, M. A. (2013) · Therapeutic Drug Monitoring · doi:10.1097/ftd.0b013e3182a5c446 · Cited by 18 · see citing works

Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.
Levin, F. R., Mariani, J. J., Pavlicova, M., Brooks, D., Glass, A., Mahony, A., Nunes, E. V., Bisaga, A., Dakwar, E., Carpenter, K. M., et al. (2016) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2015.11.025 · Cited by 109 · see citing works
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Use of Dronabinol for Cannabis Dependence: Two Case Reports and Review
LEVIN, F. R., & Kleber, H. D. (2008) · American Journal on Addictions · doi:10.1080/10550490701861177 · Cited by 35 · see citing works
Self-citation
The effect of high-dose dronabinol (oral THC) maintenance on cannabis self-administration
Schlienz, N. J., Lee, D. C., Stitzer, M. L., & Vandrey, R. G. (2018) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2018.02.022 · Cited by 31 · see citing works
The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users
Vandrey, R. G., Stitzer, M. L., Mintzer, M. Z., Huestis, M. A., Murray, J. A., & Lee, D. (2012) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2012.08.001 · Cited by 106 · see citing works
Nabilone Decreases Marijuana Withdrawal and a Laboratory Measure of Marijuana Relapse
Haney, M., Cooper, Z. D., Bedi, G., Vosburg, S. K., Comer, S. D., & Foltin, R. W. (2013) · Neuropsychopharmacology · doi:10.1038/npp.2013.54 · Cited by 132 · see citing works

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.
ORCID: Levin, Frances R.
Mariani, John J.
Cheng, Wendy
Nunes, Edward V.
Venue: Drug and Alcohol Dependence
Publisher: Elsevier BV
Published: 2011-07
Volume: 116
Issue: 1-3
Pages: 142-150
ISSN: 0376-8716 (ISSN-L)
DOI: 10.1016/j.drugalcdep.2010.12.010
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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 › Cannabis and Cannabinoid Research
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Physiology › 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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Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.

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