Gabapentin Treatment of Cannabis Dependence

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00395044

First received: November 1, 2006

Last updated: February 6, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cannabis use
Cannabis withdrawal

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00395044 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep
Mood
Craving
Cannabis use consequences

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gabapentin Treatment of Cannabis Dependence

Official Title ^ICMJE

Gabapentin for Cannabis Withdrawal and Use

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cannabis Dependence

Intervention ^ICMJE

Drug: gabapentin
Behavioral: Standardized behavioral therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00395044

Other Study ID Numbers ^ICMJE

DA020766-01, 5 R21 DA020766-01

Has Data Monitoring Committee

Responsible Party

Barbara J. Mason, Ph.D., The Scripps Research Institute

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Barbara J. Mason, Ph.D.

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

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

February 2009

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

To Top