A double-blind placebo control pilot study on the safety and tolerability of Nabilone in marijuana users

Abstract

Epidemiological studies show chronic marijuana users have poorer outcomes for both physical health and psychosocial functioning. Evidence has shown that a potential mechanism of action for marijuana's effect is the endogenous cannabinoid system and the active compound Δ⁹-tetrahydrocannabinol (THC). There is mounting evidence that marijuana withdrawal has clinically identifiable symptoms which follow a time course typical of other substance withdrawal syndromes. Substitution strategies are a typical treatment strategy in addiction treatment. Nabilone [Cesamet®] is a synthetic cannabinoid that may mediate the effects of marijuana; however this has not been evaluated in humans. Therefore, we assessed the safety of Nabilone [Cesamet®] in subjects using marijuana. Subjects were randomized into treatment (n = 22) and control (n = 22) arms, and received a three-week, daily dose of Nabilone [Cesamet®] at 1 mg/day or placebo. Safety outcomes consisted of vital signs, hematology, ECG, urinalysis, and adverse events (AE). No significant differences emerged between baseline and final visit treatment assessments on all safety outcomes between treatment arms. AE were reported in the treatment (n = 13) and placebo (n = 12) arms. The most common non-serious AE were tiredness, dry mouth, nausea, diarrhea, congestion, and drowsiness. In marijuana users, low dose Nabilone [Cesamet®] was safe and tolerated, with no serious AE.

Keywords:

• addiction
• marijuana
• Nabilone
• safety
• mental disorder

Acknowledgements

Nabilone and placebo were provided by Valeant Canada Ltd (7150 Mississauga Road Mississauga, Ontario L5N 8M5). Funding for the research was by an unrestricted, investigator-initiated grant by Valeant Canada Ltd.