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

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Mclean Hospital
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00158249

Purpose

The four main aims of this open-label outpatient study are as follows:

to develop a device and procedure that will permit smoking of a marijuana cigarette while receiving a magnetic resonance imaging (MRI) screening;
to measure the effects of smoked marijuana on brain activity;
to match those effects with changes in mood state and levels of intoxication; and
to test whether short-term treatment with citicoline will reduce marijuana use and alter the effects of smoked marijuana. It is hypothesized that changes in regional blood flow in areas associated with reinforcement will be altered immediately after smoking marijuana and that citicoline will reduce marijuana intake, but will not alter the acute effects of smoked marijuana.

Condition	Intervention	Phase
Marijuana Abuse	Drug: Citicoline	Phase II

MedlinePlus related topics: Marijuana

Drug Information available for: Choline Cytidine diphosphate choline Cannabis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Cannabis Dependence: Imaging and Medication Development - 1

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Marijuana use (measured at Week 1 to 4) [ Time Frame: Measured at weeks 1 and 4 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	September 2005
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Intervention Details:

1 gm/day, bid, oral, 4 weeks

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:	21 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Locations

United States, Massachusetts
McLean Hospital, Department of Psychiatry	Recruiting
Belmont, Massachusetts, United States, 02478 9106
Contact: Scott E. Lukas, PhD 617-855-2767 lukas@mclean.harvard.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Mclean Hospital

Investigators

Principal Investigator:

Scott E. Lukas, PhD

Mclean Hospital

More Information

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	McLean Hospital ( Scott E. Lukas, Ph.D., Director )
Study ID Numbers:	NIDA-19238-1, R01-19238-1, DPMC
Study First Received:	September 8, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00158249 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Nootropic Agents
Choline
Mental Disorders
Cytidine Diphosphate Choline

Substance-Related Disorders
Disorders of Environmental Origin
Marijuana Abuse

Additional relevant MeSH terms:

Nootropic Agents
Mental Disorders
Therapeutic Uses
Cytidine Diphosphate Choline
Substance-Related Disorders

Disorders of Environmental Origin
Central Nervous System Agents
Marijuana Abuse
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009