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 for cannabis abstinence in a recent clinical trial.
“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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Martin, E. L., Doncheck, E. M., Reichel, C. M., & McRae‐Clark, A. L. (2021) · Neurobiology of Stress · doi:10.1016/j.ynstr.2021.100364 · Cited by 14 · see citing works
Cui, Q., Bian, R., Xu, F., Li, Q., Wang, W., & Bian, Q. (2021) · Studies in natural products chemistry · doi:10.1016/b978-0-12-819487-4.00016-1 · Cited by 14 · see citing works
Imperio, C. G., LEVIN, F. R., & Martínez, D. (2024) · American Journal of Psychiatry · doi:10.1176/appi.ajp.20231023 · Cited by 13 · see citing works
Self-citationNeuronal nicotinic acetylcholine receptors mediate ∆ 9 ‐THC dependence: Mouse and human studies
Donvito, G., Muldoon, P. P., Jackson, K. J., Ahmad, U., Zaveri, N. T., McIntosh, J. M., Chen, X., Lichtman, A. H., & Damaj, M. I. (2018) · Addiction Biology · doi:10.1111/adb.12691 · Cited by 13 · see citing works
A Systematic Review of Medical Cannabinoids Dosing in Human
Campos, D. A., Mendivil, E. J., Romano, M., Garcı́a, M., & Martínez, M. E. (2022) · Clinical Therapeutics · doi:10.1016/j.clinthera.2022.10.003 · Cited by 13 · see citing works
Pharmacotherapies for cannabis use disorder
Spiga, F., Parkhouse, T., Tang, V. M., Savović, J., Foll, B. L., & Nielsen, S. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008940.pub4 · Cited by 12 · see citing works
Pressman, P., Hayes, A. W., Hoeng, J., Latino, D. A. R. S., Mazurov, A. A., Schlage, W. K., & Rana, A. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13061540 · Cited by 11 · see citing works
Gabapentin attenuates somatic signs of precipitated THC withdrawal in mice
Eckard, M. L., & Kinsey, S. G. (2021) · Neuropharmacology · doi:10.1016/j.neuropharm.2021.108554 · Cited by 10 · see citing works
Beyond monoamines: II. Novel applications for PET imaging in psychiatric disorders
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Mills, L., Dunlop, A. J., Montebello, M. E., Copeland, J., Bruno, R., Jefferies, M., McGregor, I. S., & Lintzeris, N. (2022) · Substance Abuse Treatment Prevention and Policy · doi:10.1186/s13011-022-00493-z · Cited by 9 · see citing works
“Though promising, replication of these results in additional randomised trials is necessary, and as yet there are still no FDA-approved pharmacotherapies for CUD [22].”
BackgroundInfluentialManagement of withdrawal from alcohol and other drugs
Lintzeris, N., Sunjic, S., Demirkol, A., Branezac, M., Ezard, N., Siefried, K. J., Acheson, L. S., Bascombe, F., Tremonti, C., & Haber, P. (2019) · doi:10.57022/mjjp9930 · Cited by 9 · see citing works
Sinclair, J., Kalk, N. J., Kaar, S. J., Agabio, R., Arunogiri, S., Bisaga, A. M., Chesney, E., Daly, C., Dewhurst, J., Freeman, T. P., et al. (2026) · Journal of Psychopharmacology · doi:10.1177/02698811251399593 · Cited by 8 · see citing works
“Four RCTs have investigated cannabinoid receptor partial agonists as cannabis-substi-tution therapy (Levin et al., 2011, 2016; Lintzeris et al., 2019; Trigo et al., 2018) (Ib), with mixed results on withdrawal, retention and abstinence.”
Self-citationMartin, E. L., & McRae‐Clark, A. L. (2020) · Current Addiction Reports · doi:10.1007/s40429-020-00342-8 · Cited by 8 · see citing works
Alayoubi, M., Henry, B. A., Cahill, C. M., & Cooper, Z. D. (2024) · Drugs · doi:10.1007/s40265-024-02098-1 · Cited by 7 · see citing works
“…use in a laboratory model of relapse after three days of forced abstinence with continuous measure of cannabis self-administration [41], whereas the outpatient study with treatment-seekers required that participants self-initiate abstinence prior to assessing relapse (continued abstinence) [74].”
InfluentialLile, J. A., Alcorn, J. L., Hays, L. R., Kelly, T. H., Stoops, W. W., Wesley, M. J., & Westgate, P. M. (2021) · Experimental and Clinical Psychopharmacology · doi:10.1037/pha0000464 · Cited by 7 · see citing works
Gharbi, K. A., Bonomo, Y. A., & Hallinan, C. M. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20054087 · Cited by 7 · see citing works
“Two double-blinded RCTs in large populations (n = 156,122) of longer duration (9, 10 weeks) were conducted [54,56].”
BackgroundInfluentialCannabinoids for Substance Use Disorder Treatment: What Does the Current Evidence Say?
Fernandes, J. A. B., Filev, R., & Fidalgo, T. M. (2023) · Cannabis and Cannabinoid Research · doi:10.1089/can.2023.0065 · Cited by 6 · see citing works
“24,26,28 While the clinical evidence supporting the use of plant-based CBD + THC extracts for treating SUD is still limited, recent observational studies indicate that the synergistic effects of cannabinoids and other compounds present in cannabis may improve treatment retention and reduce…”
InfluentialHuman Laboratory Models of Cannabis Use Disorder
Arout, C. A., Herrmann, E. S., & Haney, M. (2018) · Springer eBooks · doi:10.1007/978-3-319-90365-1_9 · Cited by 6 · see citing works
The Treatment of Cannabis Use Disorder
Danovitch, I., & Gorelick, D. A. (2018) · Elsevier eBooks · doi:10.1016/b978-0-323-54856-4.00007-9 · Cited by 5 · see citing works
Preto, M. C., Kortas, G. T., Blaas, I. K., Lassi, D. L. S., Campos, M. W., Torales, J. C., Ventriglio, A., Périco, C. D. A.-M., de Andrade, A. G., & Castaldelli-Maia, J. M. (2023) · International Review of Psychiatry · doi:10.1080/09540261.2023.2231540 · Cited by 4 · see citing works
“Cooper et al. (2013) had a majority of black patients, while Levin et al. (2016) had an almost equal distribution of black and white patients in both the placebo and intervention groups.”
Hudson, D., Howarth, N., Idalsoaga, F. J., Song, Y. N., Islam, A. H., Theiventhiran, S., Díaz, L. A., & Arab, J. P. (2024) · Current Hepatology Reports · doi:10.1007/s11901-024-00630-1 · Cited by 4 · see citing works
“Synthetic Cannabinoids RCTs involving dronabinol (synthetic delta-9-tetrahydrocannabinol) did not show any differences in abstinence rates between treatment with 20 mg twice daily or three times daily over 8 weeks versus placebo [152, 153].”
Sahlem, G. L., Kim, B., Baker, N. L., Wong, B. L., Caruso, M. A., Campbell, L. A., Kaloani, I., Sherman, B. J., Ford, T. J., Musleh, A. H., et al. (2023) · medRxiv · doi:10.1101/2023.07.10.23292461 · Cited by 4 · see citing works
“Notably, no pharmacotherapy trial (including full agonist therapy 11,65 ) has observed a between-group change in craving over the course of treatment using the MCQ-SF, even when finding a clinical effect.”
Cannabinoids for the treatment of cannabis abuse disorder
Rodríguez, A., & Zavala, C. (2018) · Medwave · doi:10.5867/medwave.2018.06.7286 · Cited by 3 · see citing works
Cannabinoid Drugs in Mental Health Disorders
Kloiber, S. M., Matheson, J., Kim, H. K., & Foll, B. L. (2021) · Springer eBooks · doi:10.1007/978-3-319-56015-1_465-1 · Cited by 3 · see citing works
Cannabiskonsum und Cannabiskonsumstörungen
Hoch, E., & Preuss, U. W. (2024) · Der Nervenarzt · doi:10.1007/s00115-024-01722-5 · Cited by 2 · see citing works
Cannabinoids in disorders of gut-brain interaction and gastrointestinal motility
Arboleda, M. F., Prosk, E., Watier, A., & Schmulson, M. J. (2021) · NeuroGastroLATAM Reviews · doi:10.24875/ngl.20000021 · Cited by 2 · see citing works
Nizama-Valladolid, M. (2017) · ACTA MEDICA PERUANA · doi:10.35663/amp.2017.343.410 · Cited by 2 · see citing works
Wirksamkeit, Verträglichkeit und Sicherheit von medizinischem Cannabis
Hoch, E., Schneider, M., von Keller, R., Bonnet, U., Falkai, P., Hasan, A., Häuser, W., Hinz, B., Jakob, L., Kabisch, J., et al. (2018) · Springer eBooks · doi:10.1007/978-3-662-57291-7_4 · Cited by 2 · see citing works
Empirical Analysis of the Volatility of Stock Market Based on the Improved GARCH Model
祝, 人. (2020) · Advances in Applied Mathematics · doi:10.12677/aam.2020.92017 · Cited by 2 · see citing works
Pharmacotherapy for Cannabis Use Disorder: Preclinical and Clinical Models
Bedillion, M. F., Moore, C. F., Weerts, E. M., Arout, C. A., Harris, H. M., & Haney, M. (2025) · Current topics in behavioral neurosciences · doi:10.1007/7854_2025_598 · Cited by 1 · see citing works
New Horizons in the Development of Treatments for Substance Use Disorders
Mariani, J. J., & LEVIN, F. R. (2026) · American Journal of Psychiatry · doi:10.1176/appi.ajp.20260362 · Cited by 1 · see citing works
Self-citationCannabinoids to Treat Cannabis Use Disorders
Brezing, C., & LEVIN, F. R. (2018) · Springer eBooks · doi:10.1007/978-3-319-90365-1_19 · Cited by 1 · see citing works
Self-citationCannabis Use Disorders in Primary Care: Screening and Treatment Suggestions
Turner, S., Nader, M., & Graves, L. E. (2017) · Medical Research Archives · doi:10.18103/mra.v5i7.1309
Uso medicinal de la marihuana: la discusión pendiente - Réplica
Nizama-Valladolid, M. (2018) · ACTA MEDICA PERUANA · doi:10.35663/amp.2017.344.472
“Los medicamentos derivados de los cannabinoides (dronabinol y nabilona) están indicados como paliativos de la emesis, crisis convulsivas y dolor neuropático crónico basado en estudios aleatorizados [5].”
BackgroundFerreira, J. V., Correa, L. C., da Costa, D. C., & Hage-Melim, L. I. D. S. (2019) · IntechOpen eBooks · doi:10.5772/intechopen.82184
“6 mg three times a day), with 40% of patients presenting dizziness and fatigue [69].”
BackgroundThe Research Progress of Treatment of Several Mental Disorders Using Cannabis Drugs (THC and CBD)
周, 小. (2020) · Advances in Clinical Medicine · doi:10.12677/acm.2020.102020
Cannabis Use Disorder and Its Treatment
Budney, A. J., & Sofis, M. J. (2020) · Springer eBooks · doi:10.1007/978-3-030-36391-8_12
Chapter 17. Treatment of Cannabis-Related Disorders
Brezing, C., Mitra, S., & LEVIN, F. R. (2021) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615373970.kb17
Self-citationCannabisarznei zur Behandlung psychischer Störungen
Hoch, E., Preuss, U. W., & Pogarell, O. M. (2020) · InFo Neurologie + Psychiatrie · doi:10.1007/s15005-020-1271-z
Treatment of Co-occurring Psychiatric Disorders and Cannabis Use in the Outpatient Setting
Veligati, S., & Ritvo, A. D. (2022) · Psychiatry update · doi:10.1007/978-3-031-04874-6_10
Ferreira, J. V., Chaves, G. A., Batista, M. A., Correia, L. C., de Souza, L. R., da Costa, D. C., Barcelos, M. P., da Silva, C. H. T. D. P., Taft, C. A., & Hage-Melim, L. I. D. S. (2022) · Engineering materials · doi:10.1007/978-3-031-07622-0_16
Cannabinoid Drugs in Mental Health Disorders
Kloiber, S. M., Matheson, J., Kim, H. K., & Foll, B. L. (2022) · Springer eBooks · doi:10.1007/978-3-030-62059-2_465
Gorodetzky, C. W., Gullo, K. L., & Fishman, M. J. (2023) · Oxford University Press eBooks · doi:10.1093/oxfordhb/9780197618431.013.21
Gabapentinoids for the treatment of cannabis use disorder: A focus on human laboratory research
Lile, J. A., Stoops, W. W., & Wesley, M. J. (2023) · Elsevier eBooks · doi:10.1016/b978-0-323-89862-1.00042-8
Wolinsky, D. I., & Vandrey, R. G. (2023) · Elsevier eBooks · doi:10.1016/b978-0-323-89862-1.00037-4
Disorders Due to Substance Use: Cannabis
Cousijn, J., Compton, W. M., & LEVIN, F. R. (2023) · Springer eBooks · doi:10.1007/978-3-030-42825-9_161-1
Self-citationLaurenz, L. J., & Thomasius, R. (2023) · Springer eBooks · doi:10.1007/978-3-662-65267-1_25
Mills, L., Dunlop, A. J., Montebello, M. E., Copeland, J., Bruno, R., Jefferies, M., McGregor, I. S., & Lintzeris, N. (2022) · Figshare · doi:10.6084/m9.figshare.21303200
Chapter 54. Treatment of Substance Use Disorders
Sherman, B. J., Hartwell, K. J., McRae‐Clark, A. L., Herron, A., & Brady, K. T. (2024) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615375523.as54
Disorders due to Substance Use: Cannabis
Cousijn, J., Compton, W. M., & LEVIN, F. R. (2024) · Springer eBooks · doi:10.1007/978-3-030-51366-5_161
Self-citationChapter 4. Cannabis and Cannabinoids
Rossopoulos, T., & Marienfeld, C. B. (2025) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9798894550862.lg04
Bilbao, A., & Spanagel, R. (2022) · Figshare · doi:10.6084/m9.figshare.20517185
Bilbao, A., & Spanagel, R. (2022) · Figshare · doi:10.6084/m9.figshare.20517173
- 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 · 2014: 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 › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Physiology › 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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