Cannabis Dependence Clinical Trial
Official title:
Nabilone for Cannabis Dependence: A Pilot Study
Cannabis use disorders are an important public health problem in the United States, but there are no effective medications available to treat these disorders. The investigators intend to test a medication with interesting properties, nabilone, as a treatment for cannabis dependence and to study the relationship of this treatment with the brain using functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing treatment-seeking patients to benefit from behavioral treatments when they are trying to stop using cannabis. The investigators propose to assess the relationship of nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using functional MRI brain scans. The investigators hypothesize that patients receiving nabilone will reduce their use of cannabis more than patients receiving placebo during this 10-week treatment trial.
Cannabis use disorders are an important public health problem in the United States, but no
effective pharmacotherapies are available to treat these disorders. The investigators intend
to test a novel agonist pharmacotherapy, nabilone, for cannabis dependence and to study the
relationship of this treatment with the brain using BOLD fMRI measures. The behavioral and
physiological effects of nabilone and Δ9-THC overlap, suggesting that nabilone may ameliorate
cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from
medical management (MM) sessions when they are trying to stop using cannabis. The
investigators propose to assess the relationship of nabilone, when added to MM, on cannabis
use patterns in cannabis-dependent patients. The investigators also aim to determine the
effects of nabilone on performance on neuropsychological tests and to assess the correlation
of neuropsychological performance to brain changes using BOLD fMRI measures.
In this pilot study, subjects will receive either nabilone or placebo in addition to medical
management (MM) over a 10-week treatment period. Subjects' responses to neuropsychological
testing carried out while the subject is receiving fMRI scans at 3 time points: at baseline,
4 weeks, and 10 weeks. Following treatment completion, subjects will have a follow-up visit
at 14 weeks. This pilot study will evaluate the feasibility of nabilone treatment for
cannabis dependence and will establish effect sizes for a larger trial in which subjects will
receive high-dose nabilone, low-dose nabilone, or placebo in addition to MM.
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