Cannabis Dependence Clinical Trial
Official title:
Gabapentin Treatment of Cannabis Dependence
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Scripps Research Institute | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
The Scripps Research Institute | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cannabis Use | Urinary THC | Measured 1x per week for 12 weeks | No |
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