Clinical trial NCT00395044: Gabapentin Treatment of Cannabis Dependence
Official title: Gabapentin for Cannabis Withdrawal and Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Keywords: Cannabis treatment
marijuana treatment
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a 12-week, double blind, placebo controlled, dose ranging 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.

Eligibility criteria: Inclusion Criteria:

* Males or females age 18-65 with cannabis dependence
* Meets DSM-IV-TR criteria for Cannabis Dependence
* Smoked marijuana at least once a week in the 90 days prior to study participation
* Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

* Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month

Primary outcomes:
measure: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
timeFrame: Week 0 and Week 12
Secondary outcomes:
measure: Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12
timeFrame: Week 0 and Week 12
measure: Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12
timeFrame: Week 0 and Week 12
measure: Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12
timeFrame: Week 0 and Week 12
measure: Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12
timeFrame: Week 0 and Week 12
measure: Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12
timeFrame: Week 0 and Week 12
measure: Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4
timeFrame: Week 0 and Week 4
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mason BJ, Crean R, Goodell V, Light JM, Quello S, Shadan F, Buffkins K, Kyle M, Adusumalli M, Begovic A, Rao S. A proof-of-concept randomized controlled study of gabapentin: effects on cannabis use, withdrawal and executive function deficits in cannabis-dependent adults. Neuropsychopharmacology. 2012 Jun;37(7):1689-98. doi: 10.1038/npp.2012.14. Epub 2012 Feb 29.