Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2009-11-04
2016-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Gabapentin 1200mg/day
1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
Manual-guided behavioral counseling
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Placebo
1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Placebo
1200mg/day of placebo for 12 weeks
Manual-guided behavioral counseling
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Interventions
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gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
Placebo
1200mg/day of placebo for 12 weeks
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The Scripps Research Institute
OTHER
Responsible Party
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Barbara J. Mason
PI
Principal Investigators
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Barbara J Mason, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Scripps Research Institute
Locations
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The Scripps Research Institute
La Jolla, California, United States
Countries
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Related Links
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Study Website
Other Identifiers
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DA026758
Identifier Type: -
Identifier Source: org_study_id
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