Cannabis Dependence | Gabapentin Treatment of Cannabis Dependence
Cannabis Dependence research study
What is the primary objective of this study?
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:gabapentin 1200mg/daygabapentin 1200mg/day for 12 weeks
Drug:Placebo1200mg/day of placebo for 12 weeks
Behavioral:Manual-guided behavioral counselingStandardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Gabapentin 1200mg/day1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Placebo1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Start Date: November 4, 2009
Completed Date: May 19, 2016
Phase: Phase 2
Primary Outcome: Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Study sponsors, principal investigator, and references
Principal Investigator: Barbara J Mason, Ph.D.
Lead Sponsor: The Scripps Research Institute
Collaborator: National Institute on Drug Abuse (NIDA)