Kampman 2011.
| Trial name or title | A phase II, double‐blind, placebo‐controlled, pilot trial of vigabatrin for the treatment of cocaine and alcohol dependence |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 60 participants Inclusion criteria: both genders; 18 years of age or older; meeting DSM‐IV criteria for current diagnoses of cocaine and alcohol dependence; three consecutive days of abstinence from alcohol directly before the day of randomisation; verifiable address of principal residence and agreeing to attend all research visits including follow‐up visits; speaking, understanding and printing in English; able to give informed consent Exclusion criteria: meets DSM‐IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis); needing treatment with any psychoactive medications; meeting current or lifetime DSM‐IV criteria for schizophrenia or organic mental disorder or meeting current DSM‐IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation; evidence of history of significant haematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease; severe physical or medical illness such as AIDS, active hepatitis, significant hepatocellular injury; use of an investigational medication in the 30 days before randomisation; history of prior treatment with vigabatrin; history of prior treatment with drugs with known retinotoxicity; history of visual field defects or predisposing factors; female positive on a pregnancy test, contemplating pregnancy in the next six months, nursing or not using an effective contraceptive method |
| Interventions | (1) Vigabatrin; (2) placebo Drug dose: vigabatrin up to 3000 mg/d Duration: eight weeks. Country of origin: USA |
| Outcomes | Primary outcomes: reduction in cocaine use (number of benzoylecgonine (BE) negative urine samples); alcohol abstinent days and heavy drinking days Secondary outcomes: measures of cocaine and alcohol craving; addiction severity (ASI); disease severity and improvement; alcohol and cocaine withdrawal severity (CIWA and Cocaine Selective Severity Assessment); depression and anxiety (HDRS and HARS) |
| Starting date | April 2011 |
| Contact information | Donna Simpson, +121 524 39959, addicted@med.upenn.edu, University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania, United States 19104 |
| Notes |