Gabapentin Treatment of Cannabis Dependence - Full Text View

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

ChemIDplus related topics:

Gabapentin Cannabis GW-1000

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Gabapentin for Cannabis Withdrawal and Use

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

Responsible Party:	The Scripps Research Institute ( Barbara J. Mason, Ph.D. )
Study ID Numbers:	DA020766-01
First Received:	November 1, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00395044
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

Study placed in the following topic categories:

Excitatory Amino Acids

Gabapentin

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Marijuana Abuse

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antiparkinson Agents

Calcium Channel Blockers

Excitatory Amino Acid Agents

Cardiovascular Agents

Antimanic Agents

Pharmacologic Actions

Membrane Transport Modulators

Sensory System Agents

Therapeutic Uses

Anti-Anxiety Agents

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 23, 2008

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