Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00218660
Brief Summary:
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, CBT, 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, BRENDA, 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.
Detailed Description:
The project will use a 2x2 design to assess the efficacy of naltrexone for treating subjects who are both cocaine and alcohol dependent and who will receive either CBT or BRENDA alone or in combination with naltrexone. There will be 300 DSM-IV cocaine-alcohol dependent male and female subjects randomized to one of four groups (75 subjects per group). Subjects will be randomized to either 150mg/day naltrexone or placebo and to receive either CBT (a type of cognitive behavior therapy derived from relapse prevention principles), or a new primary-care basedmodel, BRENDA, comprised of strategies for enhancing motivation and treatment compliance. All subjects will receive one of the four combinations of medication and psychosocial treatment. The length of the study for each subject includes one week of screening/baseline assessments, 12 weeks of double-blind, placebo-controlled naltrexone treatment combined with one of two psychosocial treatments, and a 6-month and 12-month follow-up visit. Following successful completion of detoxification (abstinence from alcohol and cocaine for 7 days), informed consent will be signed, and Week 1 will be devoted to completing screening and baseline measures. In Week 2, subjects will be randomly assigned to medication/ psychosocial treatment combination. Following completion of the 12-week, double-blind treatment trial, subjects will be evaluated at 6-month and 12-months post-treatment visits.
Study:
NCT00218660
Study Brief:
Protocol Section:
NCT00218660