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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00158249
First received: September 8, 2005
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Marijuana Abuse
Drug: citicoline
Drug: placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Marijuana Use [ Time Frame: Measured for 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurocognitive Function [ Time Frame: Before and after 8 weeks of treatment ] [ Designated as safety issue: No ]
    Multiple Source Interference Test (MSIT)


Enrollment: 21
Study Start Date: September 2009
Study Completion Date: October 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
matched capsules
Drug: placebo
matched for physical appearance
Experimental: citicoline
2 gm/day
Drug: citicoline
2 gm/day, 8 weeks 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158249

Locations
United States, Massachusetts
McLean Hospital, Department of Psychiatry
Belmont, Massachusetts, United States, 02478 9106
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Scott E. Lukas, PhD Mclean Hospital
  More Information

Additional Information:
No publications provided by Mclean Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Lukas, Director, MIC & BPRL, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00158249     History of Changes
Other Study ID Numbers: NIDA-19238-1, R01DA019238, DPMC, R01DA024007
Study First Received: September 8, 2005
Results First Received: October 15, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
citicoline, drug abuse, marijuana

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cytidine Diphosphate Choline
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014