Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

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: Jose M Trigo, Alexandra Soliman, Lena C Quilty, Benedikt Fischer, Jürgen Rehm, Peter Selby, Allan J Barnes, Marilyn A Huestis, Tony P George, David L Streiner, Gregory Staios, Bernard Le Foll
• Journal: PloS one (PLoS One) Vol. 13 Issue 1 Pg. e0190768 ( 2018) ISSN: 1932-6203 [Electronic] United States
• PMID: 29385147 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Drug Combinations
• Placebos
• Cannabidiol
• Dronabinol
• nabiximols

Topics

• Adult
• Cannabidiol (therapeutic use)
• Cognitive Behavioral Therapy
• Craving
• Double-Blind Method
• Dronabinol (therapeutic use)
• Drug Combinations
• Female
• Humans
• Male
• Marijuana Abuse (therapy)
• Middle Aged
• Motivation
• Pilot Projects
• Placebos
• Substance Withdrawal Syndrome (therapy)
• Young Adult