Gabapentin Treatment of Cannabis Dependence

This study has been completed.

First Received: November 1, 2006 Last Updated: February 6, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00395044

Purpose

This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Condition	Intervention	Phase
Cannabis Dependence	Drug: gabapentin Behavioral: Standardized behavioral therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Gabapentin for Cannabis Withdrawal and Use

Resource links provided by NLM:

Drug Information available for: GW-1000 Gabapentin Cannabis

U.S. FDA Resources

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

Primary Outcome Measures:

Cannabis use
Cannabis withdrawal

Secondary Outcome Measures:

Sleep
Mood
Craving
Cannabis use consequences

Enrollment:	50
Study Start Date:	August 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females age 18-65 with cannabis dependence
Meets DSM-IV-TR criteria for Cannabis Dependence
Smoked marijuana at least once a week in the 90 days prior to study participation
Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
Significant medical disorders that will increase potential risk or interfere with study participation
Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
Treatment with an investigational drug in the last month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395044

Locations

United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Barbara J. Mason, Ph.D.

The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research

More Information

No publications provided

Responsible Party:	The Scripps Research Institute ( Barbara J. Mason, Ph.D. )
Study ID Numbers:	DA020766-01, 5 R21 DA020766-01
Study First Received:	November 1, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00395044 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

Cannabis treatment
marijuana treatment

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Membrane Transport Modulators
Sensory System Agents
Mental Disorders
Therapeutic Uses

Substance-Related Disorders
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Marijuana Abuse
Pharmacologic Actions
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010