drugset / Trial / NCT00004554

Sertraline for Alcohol Dependence and Depression

NCT00004554

Phase 4 Completed 171 enrolled University of Pennsylvania
RandomizedFactorialQuadruple-blindTreatment

Summary

This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.

Timeline

Start
2000-01
Primary completion
2005-08
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 100 mg
Subject Sertraline Small molecule 200 mg