Vigabatrin for Cocaine and Alcohol Dependence (VGB)
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|ClinicalTrials.gov Identifier: NCT01335867|
Recruitment Status : Terminated (interim analysis of efficacy completed and termination recommended)
First Posted : April 14, 2011
Results First Posted : June 12, 2015
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Cocaine Dependence||Drug: Vigabatrin Drug: Placebo||Phase 2|
The hypotheses in the proposed study will be tested with a 2-group design to assess the efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.
Study medication will be initiated in Week 2. The research physician will explain the dosing regimen and subjects will be randomly assigned to receive either vigabatrin or identical placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53, and to 1 gram on days 54-56
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||December 2013|
Vigabatrin titrated to 3 grams daily for 8 weeks
Vigabatrin escalated to 3 grams daily for 8 weeks
Other Name: Sabril
Placebo Comparator: Placebo
Identical placebo daily for three weeks
Other Name: placebo vigabatrin
- Number of Participants With a Reduction in Cocaine Use [ Time Frame: last 3 weeks of the trial ]The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.
- Proportion of Heavy Drinking Days [ Time Frame: 8 weeks ]The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.
- Measures of Cocaine Craving [ Time Frame: 8 weeks ]Measures of cocaine craving at the end of the trial will be measured using the Brief Substance Craving Ccale. Craving intensity + Craving frequency + Craving Duration each measured on a 4 point scale. Sum of the three scales was overall craving composite. Higher numbers meaning greater craving. Maximum score 12 minimum 0.
- Disease Severity and Improvement [ Time Frame: 8 weeks ]Number of subjects in each group rated as improved or very much improved at the end of the trial
- Cocaine Withdrawal Severity [ Time Frame: 8 weeks ]Measure of cocaine withdrawal severity will include Cocaine Selective Severity Assessment scores. Minimum score is 0 Maximum score is 119 Higher score is indicative of worse cocaine withdrawal symptoms.
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): NCT01335867
|United States, Pennsylvania|
|University of Pennsylvania, Treatment Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kyle M Kampman, M.D.||University of Pennsylvania|