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 ]

Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.


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