Gabapentin Treatment of Cannabis Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Scripps Research Institute
Sponsor:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00974376
First received: September 1, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Cannabis Dependence
Cannabis Withdrawal
Cognitive Deficits
Drug: gabapentin 1200mg/day
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin Treatment of Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Cannabis Use [ Time Frame: Measured 1x per week for 12 weeks ] [ Designated as safety issue: No ]
    CN-THCCOOH ratio measured in the urine


Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin 1200mg/day
1200mg/day of gabapentin
Drug: gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
Other Name: Neurontin
Placebo Comparator: Placebo
1200mt/day placebo
Drug: Placebo
1200mg/day of placebo

Detailed Description:

This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Baseline assessments using measurement instruments are conducted on cannabis use, neuropsychological functioning, withdrawal, craving, pain, mood and sleep. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months and include assessments in withdrawal, craving, pain, mood and sleep. A final, follow-up visit occurs at the end of the 3 months.

  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 from 18-65 years of age
  • Meets DSM IV criteria for current cannabis dependence
  • Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
  • Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
  • At least a 2-year history of regular MJ use

Exclusion Criteria:

  • Abstinent from cannabis more than 2 days at the time of randomization
  • Active suicidal ideation
  • Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
  • Significant medical disorders that will increase potential risk or interfere with study participation,
  • Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
  • Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
  • Inability to understand and/or comply with the provisions of the protocol and consent form
  • Treatment with an investigational drug during the previous month
  • Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
  • Ongoing treatment with medications that may affect study outcomes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974376

Contacts
Contact: Nick J. Chesher, Ph.D. (858) 784-7465 nchesher@scripps.edu

Locations
United States, California
The Scripps Research Institute Recruiting
La Jolla, California, United States, 92037
Contact: Nick J. Chesher, Ph.D.    858-784-7465    nchesher@scripps.edu   
Principal Investigator: Barbara J Mason, Ph.D.         
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00974376     History of Changes
Other Study ID Numbers: DA026758, DA026758
Study First Received: September 1, 2009
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Scripps Research Institute:
Cannabis Treatment
Cannabis Use
Cannabis Dependence
Executive Functioning
Cognitive Deficits

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced 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 August 21, 2014