NCT00004554

Sertraline for Alcohol Dependence and Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.

Conditions

• Alcoholism
• Depression

Interventions

Type	Name	Description
DRUG	naltrexone (Revia)	100mg/day
DRUG	sertraline (Zoloft)	200mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2000-01-01
• Primary completion: 2005-08-01
• Completion: 2006-02-01
• First posted: 2000-02-07
• Last updated: 2015-10-06

Locations

1 site across 1 country: United States