Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00158249
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE October 15, 2014
Results First Posted Date  ICMJE October 22, 2014
Last Update Posted Date October 22, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Marijuana Use [ Time Frame: Measured for 8 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Marihuana use measured at weeks 1-4
Change History Complete list of historical versions of study NCT00158249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Neurocognitive Function [ Time Frame: Before and after 8 weeks of treatment ]
Multiple Source Interference Test (MSIT)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
Official Title  ICMJE Cannabis Dependence: Imaging and Medication Development - 1
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Abuse
Intervention  ICMJE
  • Drug: citicoline
    2 gm/day, 8 weeks treatment
  • Drug: placebo
    matched for physical appearance
Study Arms  ICMJE
  • Placebo Comparator: placebo
    matched capsules
    Intervention: Drug: placebo
  • Experimental: citicoline
    2 gm/day
    Intervention: Drug: citicoline
Publications * Bracken BK, Penetar DM, Rodolico J, Ryan ET, Lukas SE. Eight weeks of citicoline treatment does not perturb sleep/wake cycles in cocaine-dependent adults. Pharmacol Biochem Behav. 2011 Jun;98(4):518-24. doi: 10.1016/j.pbb.2011.03.003. Epub 2011 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
21
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
0
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00158249
Other Study ID Numbers  ICMJE NIDA-19238-1
R01DA019238 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
R01DA024007 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Lukas, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Scott E. Lukas, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP