Gabapentin Treatment of Cannabis Dependence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|