The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
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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Cites
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The Cannabis Youth Treatment (CYT) Study: Main findings from two randomized trials
Dennis, M. L., Godley, S. H., Diamond, G., Tims, F. M., Babor, T. F., Donaldson, J., Liddle, H. A., Titus, J. C., Kaminer, Y., Webb, C. P. M., et al. (2004) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2003.09.005 · Cited by 780
Timeline Follow-Back: A Technique for Assessing Self-Reported Alcohol Consumption
Sobell, L. C., & Sobell, M. B. (1992) · NSUWorks (Nova Southeastern University) · Cited by 779
Cannabinoids in medicine: A review of their therapeutic potential
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Topiramate for Treating Alcohol Dependence<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>
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Marijuana withdrawal among adults seeking treatment for marijuana dependence.
Budney, A. J., Novy, P. L., & Hughes, J. R. (1999) · Addiction · doi:10.1046/j.1360-0443.1999.94913114.x · Cited by 348 · cited 2×
“” Marijuana withdrawal was assessed using the withdrawal checklist (Budney et al., 1999), a 10-item self-report instrument in which symptoms are rated either none, mild, moderate or severe (ranging respectively from 0-3) for a possible total score of 30.”
MethodSAFTEE: a technique for the systematic assessment of side effects in clinical trials.
Levine, J., & Schooler, N. (1986) · PubMed · Cited by 330
A Double-Blind Randomized Controlled Trial of N -Acetylcysteine in Cannabis-Dependent Adolescents
Gray, K. M., Carpenter, M. J., Baker, N. L., DeSantis, S. M., Kryway, E., Hartwell, K. J., McRae-Clark, A. L., & Brady, K. T. (2012) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2012.12010055 · Cited by 306
Cited by
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Cannabis use and cannabis use disorder
Connor, J. P., Stjepanović, D., Le Foll, B., Hoch, E., Budney, A. J., & Hall, W. D. (2021) · Nature Reviews Disease Primers · doi:10.1038/s41572-021-00247-4 · Cited by 552
Sex-Dependent Effects of Cannabis and Cannabinoids: A Translational Perspective
Cooper, Z. D., & Craft, R. M. (2017) · Neuropsychopharmacology · doi:10.1038/npp.2017.140 · Cited by 369
“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).”
BackgroundCannabis Addiction and the Brain: a Review
Zehra, A., Burns, J. A., Liu, C. K., Manza, P., Wiers, C. E., Volkow, N. D., & Wang, G. (2018) · Journal of Neuroimmune Pharmacology · doi:10.1007/s11481-018-9782-9 · Cited by 277
Bilbao, A., & Spanagel, R. (2022) · BMC Medicine · doi:10.1186/s12916-022-02459-1 · Cited by 181
Pharmacotherapies for cannabis dependence.
Marshall, K., Gowing, L., Ali, R., & Le Foll, B. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008940.pub2 · Cited by 156
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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