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Gabapentin Treatment of Cannabis Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00974376
First received: September 1, 2009
Last updated: May 8, 2017
Last verified: May 2017
September 1, 2009
May 8, 2017
November 4, 2009
May 19, 2016   (Final data collection date for primary outcome measure)
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period [ Time Frame: 12 weeks ]
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
  • Cannabis Use [ Time Frame: Weekly ]
  • Cannabis Withdrawal [ Time Frame: Weekly ]
  • Executive Functioning [ Time Frame: Baseline, Week 4 and Week 12 ]
Complete list of historical versions of study NCT00974376 on ClinicalTrials.gov Archive Site
Not Provided
  • Sleep [ Time Frame: Weekly ]
  • Mood [ Time Frame: Weekly ]
  • Craving [ Time Frame: Weekly ]
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. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 for 12 weeks
  • Behavioral: Manual-guided behavioral counseling
    Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
    Other Name: Manual-guided therapy
  • Experimental: Gabapentin 1200mg/day
    1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
    Interventions:
    • Drug: gabapentin 1200mg/day
    • Behavioral: Manual-guided behavioral counseling
  • Placebo Comparator: Placebo
    1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
    Interventions:
    • Drug: Placebo
    • Behavioral: Manual-guided behavioral counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 19, 2016
May 19, 2016   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00974376
DA026758
5R01DA026758-05 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Barbara J. Mason, The Scripps Research Institute
The Scripps Research Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
The Scripps Research Institute
May 2017

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