Nabiximols Plus Therapy Helped Cannabis Users Cut Their Use by 70% | Research

The takeaway

In a pilot trial, cannabis-dependent patients receiving nabiximols (THC+CBD spray) alongside behavioral therapy reduced their cannabis use by 70.5%, though this was not statistically different from the 42.6% reduction seen with placebo plus therapy.

Addiction medicine specialists, cannabis users wanting to quit, pharmacotherapy researchers.

Cannabis use reduction: 70.5% with nabiximols vs 42.6% with placebo. No serious adverse events in either group.

What the researchers found

Nabiximols was well-tolerated with no serious adverse events. Cannabis use was reduced in both groups (nabiximols 70.5% vs placebo 42.6%), though the difference was not statistically significant. Nabiximols reduced cannabis craving but did not significantly improve abstinence rates or withdrawal scores versus placebo. Participants could not distinguish nabiximols from placebo effects.

Why it matters

There are no approved medications for cannabis use disorder. This pilot trial demonstrates that nabiximols is safe and tolerable in cannabis-dependent patients, and both groups achieved substantial use reductions when combined with behavioral therapy.

The numbers in context

40 participants. Nabiximols dose up to 113.4 mg THC/105 mg CBD daily for 12 weeks. Cannabis use reduction: 70.5% (nabiximols) vs 42.6% (placebo). Participants could not tell nabiximols from placebo.

How the study worked

Double-blind, randomized clinical trial with 40 treatment-seeking cannabis-dependent participants. Self-titrated nabiximols (up to 113.4 mg THC/105 mg CBD daily) or placebo for 12 weeks, plus Motivational Enhancement Therapy and Cognitive Behavioral Therapy.

What this study cannot tell us

Small sample (n=40). Underpowered to detect between-group differences. Both groups received effective behavioral therapy, potentially masking medication effects. Self-titration may have led to suboptimal dosing.

How to read the evidence

Preliminary - small pilot trial not powered for efficacy, though the RCT design is rigorous.

When this study was published

Published in 2018.

The bigger picture

This pilot adds to growing evidence for cannabinoid agonist replacement therapy for cannabis dependence. While the between-group difference was not significant (likely due to small sample size), the trend and craving reduction support larger trials.

Questions still open

Would fixed higher dosing of nabiximols show a clearer advantage? Is the craving reduction clinically meaningful for preventing relapse? Would nabiximols be more effective without concurrent behavioral therapy (to reduce placebo response)?

Common questions

Can nabiximols (Sativex) help people quit cannabis?

This pilot trial found that nabiximols plus behavioral therapy reduced cannabis use by 70.5% and craving, though the placebo group also reduced use substantially (42.6%). The medication was safe and well-tolerated. Larger trials with higher doses were recommended.

What medications are available for cannabis addiction?

No medications are currently FDA-approved for cannabis use disorder. This trial tested nabiximols (a THC+CBD spray) as an agonist replacement therapy and found promising but not statistically significant results, suggesting this approach deserves further study.

Read the original research

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

PloS one, 13(1), e0190768

View on PubMed ↗Publisher’s paper ↗

Citation

Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard. (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