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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:11/8/2014
Start Date:September 2005
End Date:August 2014

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Cannabis Dependence: Imaging and Medication Development - 1

The Three Aims of this study are:

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 4-week treatment period
as measured in their natural environments. The same participants will experience
greater increases in brain activation in response to both marihuana challenge and
placebo marihuana during weeks 2 and 4 of the citicoline treatment period compared to
placebo-citicoline treated participants.

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 (4 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 (4 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.

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.

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
We found this trial at
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Belmont, Massachusetts 02478
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Belmont, MA
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