Gabapentin Treatment of Cannabis Dependence
|ClinicalTrials.gov Identifier: NCT00395044|
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Dependence||Drug: Placebo Drug: Gabapentin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Gabapentin for Cannabis Withdrawal and Use|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
1200 mg/daily of Gabapentin
Placebo Comparator: Placebo
1200mg/d of Placebo
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395044
|United States, California|
|The Scripps Research Institute|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Barbara J. Mason, Ph.D.||The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research|