Clinical Trial: Gabapentin Treatment of Cannabis Dependence
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Gabapentin for Cannabis Withdrawal and Use
Brief Summary: This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Detailed Summary: 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.
Sponsor: The Scripps Research Institute
Current Primary Outcome: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 [ Time Frame: Week 0 and Week 12 ]
Original Primary Outcome:
- Cannabis use
- Cannabis withdrawal
Current Secondary Outcome:
- Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 [ Time Frame: Week 0 and Week 12 ]The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).
- Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 [ Time Frame: Week 0 and Week 12 ]The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).
- Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 [ Time Frame: Week 0 and Week 12 ]The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).
- Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 [ Time Frame: Week 0 and Week 12 ]The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).
- Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 [ Time Frame: Week 0 and Week 12 ]The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).
- Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 [ Time Frame: Week 0 and Week 4 ]The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.
Original Secondary Outcome:
- Sleep
- Mood
- Craving
- Cannabis use consequences
Information By: The Scripps Research Institute
Dates:
Date Received: November 1, 2006
Date Started: August 2006
Date Completion:
Last Updated: December 19, 2016
Last Verified: December 2016