Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence
The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational.
We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Naltrexone and Psychosocial Treatments for the Treatment of Cocaine Dependence Complicated by Alcohol Dependence|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167232
|United States, Pennsylvania|
|University of Pennsylvania- Treatment Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Helen M Pettinati, PhD||University of Pennsylvania|