Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Marijuana dependence is an important public health problem in the United States, yet still no
      effective therapies are available. It is unclear how marijuana affects brain function after
      acute or chronic use. Knowing about the changes in brain function during marijuana dependence
      would aid in the understanding of the neurobiological basis of marijuana abuse and serve as a
      foundation for the development of new treatment medications for this disorder. New and
      improved brain imaging techniques, such as functional MRI (fMRI) and magnetic resonance
      spectroscopy (MRS), allow the viewing of these subtle, yet important, changes in brain
      function.

      Citicoline is used to treat victims of head trauma and neurodegenerative disorders. It has
      been found to be effective in reducing cocaine use and craving, and it has no known side
      effects. It has also been shown to reduce marijuana use. This is likely due to citicoline's
      ability to reduce insomnia and craving, act as a mild antidepressant, and improve cognitive
      function. How citicoline reduces drug use may be related to effects on cerebral blood flow
      and/or brain phospholipid metabolism in the reward areas of the brain.

      This study will determine whether citicoline alters marijuana use patterns, reduces craving,
      and affects brain phospholipids and metabolism in marijuana-dependent people. The outcome of
      the study could offer important insights into the pathophysiology and course of marijuana
      dependence. Furthermore, this study's outcome could potentially relate to other drug
      dependence disorders.
    

Intervention name(s): citicoline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 gm/day, 8 weeks treatment; matched for physical appearance
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: citicoline, drug abuse, marijuana