Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Intervention: citicoline; placebo
Intervention description: 2 gm/day, 8 weeks treatment; matched for physical appearance
Intervention MeSH terms: Cytidine Diphosphate Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: citicoline, drug abuse, marijuana

Summary:

      The Three Aims of this study are (only studies for Aim 1 were completed)

        1. Measure the impact of citicoline on marihuana use patterns in subjects' individualized
           natural settings and responses to marihuana challenge using functional brain MRI scans.

           Hypothesis - 2 g/day citicoline will produce greater reductions in marihuana use and
           craving in heavy marihuana users than placebo citicoline over a 8-week treatment period
           as measured in their natural environments. The same participants will experience greater
           improved brain activation patterns and an improvement in cognitive functioning compared
           to placebo controlled subjects.

        2. Measure the effects of citicoline on marihuana absorption and metabolism and determine
           if these changes parallel changes in subjective and physiological responses in a
           laboratory setting.

           Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will produce increases
           in subjective and physiological effects of both acute marihuana smoking and placebo
           marihuana smoking compared to chronic placebo citicoline. Citicoline will have no effect
           on marihuana pharmacokinetics.

        3. Measure the effects of citicoline on marijuana-induced cue-induced craving and brain
           electrical activity (EEG).

      Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will reduce objective
      measures of marijuana cue-reactivity, and subjective reports of craving in response to
      marihuana cues will also be attenuated compared to chronic placebo citicoline treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for current marijuana dependence

          -  Women with a negative pregnancy test prior to study entry

          -  Heavy smoker, defined as smoking more than 10 joints per week

        Exclusion Criteria:

          -  Abnormal electrocardiogram (ECG)

          -  Medical disorder that requires prescription medication

          -  Psychiatric disorder that requires prescription medication

          -  Abnormal liver function tests

          -  Taking herbal preparations

          -  Taking any over-the-counter medications on a chronic basis

          -  Pregnancy or breast feeding

          -  Neurological, infectious, or neoplastic disease

          -  Currently seeking treatment for marijuana abuse

          -  Meets criteria for alcohol, cocaine, or opioid dependence