Phase 2 N=50 Randomized Triple-blind Treatment

Gabapentin Treatment of Cannabis Dependence

Cannabis Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00395044 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 — -966.00; -532.81 ng/ml — p=.029

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Gabapentin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Scripps Research Institute
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12	-966.00; -532.81	.029 sig
SECONDARY Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12	1.42; 2.12	—
SECONDARY Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12	-4.27; -1.72	—
SECONDARY Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12	3.71; 5.22	—
SECONDARY Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12	-1.55; -1.46	—
SECONDARY Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12	-3.40; -4.90	—
SECONDARY Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4	.28; -.20	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00395044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.