Gabapentin Treatment of Cannabis Dependence

Condition(s) targeted: Cannabis Dependence; Cannabis Withdrawal; Cognitive Deficits

Intervention: gabapentin 1200mg/day (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Scripps Research Institute

Official(s) and/or principal investigator(s):
Barbara J Mason, Ph.D., Principal Investigator, Affiliation: The Scripps Research Institute

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

This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Official title: Gabapentin Treatment of Cannabis Dependence

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Cannabis Use

Cannabis Withdrawal

Executive Functioning

Secondary outcome:

Sleep

Mood

Craving

Detailed description: This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

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

The Scripps Research Institute, La Jolla, California 92037, United States; Recruiting
Rebecca Crean, Ph.D., Phone: 858-784-7334, Email: rcrean@scripps.edu
Barbara J Mason, Ph.D., Principal Investigator
Rebecca Crean, Ph.D., Sub-Investigator

Starting date: August 2009
Ending date: June 2014
Last updated: September 9, 2009