Text Size

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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Gabapentin for Cannabis Withdrawal and Use

Resource links provided by NLM:

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: Barbara J. Mason, Ph.D., The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00395044     History of Changes
Other Study ID Numbers: DA020766-01, 5 R21 DA020766-01
Study First Received: November 1, 2006
Last Updated: February 6, 2009
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:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
 Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 19, 2013