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Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.
Open accessAbstract
Background Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence.Objective 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, and lofexidine, an alpha-2 agonist, in treating cannabis dependence.Methods One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method.Results There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9% for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time.Conclusions Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder.
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“dronabinol produced no greater effects than placebo when combined with lofexidine (an agonist of the α2-adrenergic receptor) for cannabis abstinence in a recent clinical trial 52.”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [52]
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“Clinical trials investigating potential pharmacotherapies to treat CUD do not typically assess outcomes according to sex (recent studies include Allsop et al, 2014; Levin et al, 2016).”
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Metadata
- Authors
- Levin, F. R., Mariani, J. J., Pavlicova, M., Brooks, D., Glass, A., Mahony, A., Nunes, E. V., Bisaga, A., Dakwar, E., Carpenter, K. M., Sullivan, M. A., & Choi, J. C.
- Affiliations
- New York State Psychiatric Institute (US)
- Corresponding author
- Levin, Frances R.
- ORCID
- Venue
- Drug and Alcohol Dependence
- Publisher
- Elsevier BV
- Published
- 2016-02
- Volume
- 159
- Pages
- 53-60
- ISSN
- 0376-8716 (ISSN-L)
- PMC
- PMC4729291
- OpenAlex
- W2174050801
- Cited by
- 109
- References
- 34
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 8 · 2023: 10 · 2022: 18 · 2021: 15 · 2020: 10 · 2019: 9 · 2018: 21 · 2017: 5 · 2016: 1
- FWCI
- 6.48
- 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 (K02DA000465, P50 DA-09236, P50DA009236, K24DA029647)
- 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
- cannabis use disorder, dronabinol, lofexidine, delta-9-tetrahydrocannabinol, alpha-2 adrenergic agonists, combined pharmacotherapy, abstinence, withdrawal symptoms, motivational enhancement therapy, relapse prevention, treatment efficacy
- MeSH terms
- Adolescent, Adult, Marijuana Abuse, Clonidine, Double-Blind Method, Female, Humans, Male, Middle Aged, Narcotic Antagonists, Substance Withdrawal Syndrome, Dronabinol, Drug Monitoring, Secondary Prevention, Cannabinoid Receptor Agonists, Craving
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