Gabapentin Treatment of Cannabis Dependence

This study is currently recruiting participants.
Verified January 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: January 30, 2014
Last verified: January 2014

September 1, 2009
January 30, 2014
August 2009
March 2014   (final data collection date for primary outcome measure)
Cannabis Use [ Time Frame: Measured 1x per week for 12 weeks ] [ Designated as safety issue: No ]
CN-THCCOOH ratio measured in the urine
  • Cannabis Use [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Cannabis Withdrawal [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Executive Functioning [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00974376 on ClinicalTrials.gov Archive Site
Not Provided
  • Sleep [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Craving [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gabapentin Treatment of Cannabis Dependence
Gabapentin Treatment of Cannabis Dependence

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cannabis Dependence
  • Cannabis Withdrawal
  • Cognitive Deficits
  • Drug: gabapentin 1200mg/day
    gabapentin 1200mg/day for 12 weeks
    Other Name: Neurontin
  • Drug: Placebo
    1200mg/day of placebo
  • Experimental: Gabapentin 1200mg/day
    1200mg/day of gabapentin
    Intervention: Drug: gabapentin 1200mg/day
  • Placebo Comparator: Placebo
    1200mt/day placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Nick J. Chesher, M.A. (858) 784-7465 rcrean@scripps.edu
United States
 
NCT00974376
DA026758, DA026758
No
Barbara J. Mason, The Scripps Research Institute
The Scripps Research Institute
Not Provided
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
The Scripps Research Institute
January 2014

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