Nabilone for Cannabis Dependence: A Pilot Study
Condition: Cannabis Dependence; Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nabilone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): nabilone titrated to 1 mg by mouth twice daily; one placebo capsule by mouth twice daily
Other intervention name(s): Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis dependence; marijuana dependence; cannabis use disorders; cannabis withdrawal; nabilone