Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals

Completed · Phase 2 · Has a placebo group

Conditions studied: Marijuana Abuse

In brief

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.

Key facts

Study ID

NCT00158249

Run by

Mclean Hospital

People needed

21

Starts

2009-09-01

Expected to finish

2014-10-01

Last updated by the study team

2014-10-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McLean Hospital, Department of Psychiatry — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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