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Completed

NCT Number: NCT00158249

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

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.

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Key information

Conditions

Marijuana Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McLean Hospital, Department of Psychiatry

Belmont, Massachusetts, 02478 9106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citicoline

Drug

2 gm/day, 8 weeks treatment

Placebo

Drug

matched for physical appearance

Primary outcomes

  1. Marijuana Use

    Time frame: Measured for 8 weeks of treatment

Secondary outcomes

  1. Neurocognitive Function

    Time frame: Before and after 8 weeks of treatment

    Multiple Source Interference Test (MSIT)

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cannabis Dependence: Imaging and Medication Development - 1

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Sep 12, 2005
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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