- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158249
Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
Cannabis Dependence: Imaging and Medication Development - 1
The Three Aims of this study are (only studies for Aim 1 were completed)
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.
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.
- 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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
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Belmont, Massachusetts, United States, 02478 9106
- McLean Hospital, Department of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
matched capsules
|
matched for physical appearance
|
Experimental: citicoline
2 gm/day
|
2 gm/day, 8 weeks treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Marijuana Use
Time Frame: Measured for 8 weeks of treatment
|
Measured for 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognitive Function
Time Frame: Before and after 8 weeks of treatment
|
Multiple Source Interference Test (MSIT)
|
Before and after 8 weeks of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-19238-1
- DPMC (Other Identifier: NIDA)
- R01DA019238 (U.S. NIH Grant/Contract)
- R01DA024007 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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