Gabapentin Treatment of Cannabis Dependence

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.

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.

Intervention(s) in this Clinical Trial

• Drug: gabapentin 1200mg/day
  • gabapentin 1200mg/day for 12 weeks
• Drug: Placebo
  • 1200mg/day of placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin 1200mg/day
  • 1200mg/day of gabapentin
• Placebo Comparator: Placebo
  • 1200mt/day placebo

Primary Measures

• Cannabis Use
  • Time Frame: Weekly
    Safety Issue?: No
• Cannabis Withdrawal
  • Time Frame: Weekly
    Safety Issue?: No
• Executive Functioning
  • Time Frame: Baseline, Week 4 and Week 12
    Safety Issue?: No

Secondary Measures

• Sleep
  • Time Frame: Weekly
    Safety Issue?: No
• Mood
  • Time Frame: Weekly
    Safety Issue?: No
• Craving
  • Time Frame: Weekly
    Safety Issue?: No

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
• Experienced ≥ 2 withdrawal symptoms during prior cessation periods
• Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

• Abstinent from cannabis more than 2 days at the time of randomization
• Subjects for whom MJ is medically prescribed
• 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, e.g., plasma creatinine >1.4mg/dL
• History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
• 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, including depressive and anxiety disorders, and is in need of, or currently undergoing, pharmacotherapy
• 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, e.g., acamprosate, antidepressants, benzodiazepines, or other psychoactive medications
• Subjects for whom treatment of cannabis use is being mandated by a legal authority
• Subjects who plan to move out of the geographic area served by the Clinic prior to study completion

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: The Scripps Research Institute Other

Overall Clinical Trial Officials and Contacts

Barbara J Mason, Ph.D. Principal Investigator The Scripps Research Institute  

Overall Contact: Rebecca Crean, Ph.D. (858) 784=7334 rcrean@scripps.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00974376

Study ID Number: DA026758

ClinicalTrials.gov Identifier: NCT00974376

Health Authority: United States: Institutional Review Board

Study Website