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Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.
PLoS One. 2018; 13(1):e0190768.Plos

Abstract

BACKGROUND

The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.

METHODS

Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.

RESULTS

Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.

CONCLUSIONS

Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

Authors+Show Affiliations

Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.Campbell Family Mental Health Research Institute, CAMH, Toronto, Canada. Department of Psychiatry, University of Toronto, Toronto, Canada.Department of Psychiatry, University of Toronto, Toronto, Canada. Institute of Medical Science, University of Toronto, Faculty of Medicine, Toronto, Canada. Institute for Mental Health Policy Research, CAMH, Toronto, Canada. Centre for Applied Research in Mental Health & Addiction, Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada.Department of Psychiatry, University of Toronto, Toronto, Canada. Institute of Medical Science, University of Toronto, Faculty of Medicine, Toronto, Canada. Institute for Mental Health Policy Research, CAMH, Toronto, Canada. Addiction Policy, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. Institute of Clinical Psychology and Psychotherapy & Center of Clinical Epidemiology and Longitudinal Studies (CELOS), Technische Universität Dresden, Dresden, Germany.Department of Psychiatry, University of Toronto, Toronto, Canada. Addictions Division, CAMH, Toronto, Canada. Department of Family and Community Medicine, University of Toronto, Toronto, Canada.Chemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, United States of America.Chemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, United States of America.Department of Psychiatry, University of Toronto, Toronto, Canada. Addictions Division, CAMH, Toronto, Canada. Division of Brain and Therapeutics, CAMH, Toronto, Canada.Department of Psychiatry, University of Toronto, Toronto, Canada. Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, Canada.Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada. Addictions Division, CAMH, Toronto, Canada.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

29385147

Citation

Trigo, Jose M., et al. "Nabiximols Combined With Motivational Enhancement/cognitive Behavioral Therapy for the Treatment of Cannabis Dependence: a Pilot Randomized Clinical Trial." PloS One, vol. 13, no. 1, 2018, pp. e0190768.
Trigo JM, Soliman A, Quilty LC, et al. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial. PLoS One. 2018;13(1):e0190768.
Trigo, J. M., Soliman, A., Quilty, L. C., Fischer, B., Rehm, J., Selby, P., Barnes, A. J., Huestis, M. A., George, T. P., Streiner, D. L., Staios, G., & Le Foll, B. (2018). Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial. PloS One, 13(1), e0190768. https://doi.org/10.1371/journal.pone.0190768
Trigo JM, et al. Nabiximols Combined With Motivational Enhancement/cognitive Behavioral Therapy for the Treatment of Cannabis Dependence: a Pilot Randomized Clinical Trial. PLoS One. 2018;13(1):e0190768. PubMed PMID: 29385147.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial. AU - Trigo,Jose M, AU - Soliman,Alexandra, AU - Quilty,Lena C, AU - Fischer,Benedikt, AU - Rehm,Jürgen, AU - Selby,Peter, AU - Barnes,Allan J, AU - Huestis,Marilyn A, AU - George,Tony P, AU - Streiner,David L, AU - Staios,Gregory, AU - Le Foll,Bernard, Y1 - 2018/01/31/ PY - 2017/05/12/received PY - 2017/12/12/accepted PY - 2018/2/1/entrez PY - 2018/2/1/pubmed PY - 2018/2/22/medline SP - e0190768 EP - e0190768 JF - PloS one JO - PLoS One VL - 13 IS - 1 N2 - BACKGROUND: The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. METHODS: Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. RESULTS: Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. CONCLUSIONS: Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/29385147/Nabiximols_combined_with_motivational_enhancement/cognitive_behavioral_therapy_for_the_treatment_of_cannabis_dependence:_A_pilot_randomized_clinical_trial_ L2 - https://dx.plos.org/10.1371/journal.pone.0190768 DB - PRIME DP - Unbound Medicine ER -