Gabapentin Treatment of Cannabis Dependence

Cannabis Dependence Clinical Trial

Official title:

Gabapentin for Cannabis Withdrawal and Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395044
• Other study ID #: DA020766-01
• Secondary ID: 5 R21 DA020766-0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2006
• Last updated: February 6, 2009
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

Drug:
• gabapentin

Behavioral:
• Standardized behavioral therapy

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis use
Primary	Cannabis withdrawal
Secondary	Sleep
Secondary	Mood
Secondary	Craving
Secondary	Cannabis use consequences