Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
The Three Aims of this study are:
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.
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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Cannabis Dependence: Imaging and Medication Development - 1|
- Marijuana use (measured at Week 1 to 4) [ Time Frame: Measured at weeks 1 and 4 of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
matched for physical appearance
2 gm/day, 4 weeks treatmentDrug: placebo
matched for physical appearance
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158249
|United States, Massachusetts|
|McLean Hospital, Department of Psychiatry||Recruiting|
|Belmont, Massachusetts, United States, 02478 9106|
|Contact: Scott E. Lukas, PhD 617-855-2767 firstname.lastname@example.org|
|Principal Investigator:||Scott E. Lukas, PhD||Mclean Hospital|