Treating Alcohol Use In Older Adults With Depression

Phase 4

Completed

• Conditions: Alcoholism; Depression
• Interventions: Drug: Placebo; Drug: NALTREXONE

• Registration Number: NCT00018824
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

The purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

Detailed Description

This study aims to study 80 patients with comorbid alcohol dependence and a depressive syndrome. After appropriate detoxification, patients are started on either naltrexone 50 mg or placebo. After one week, sertraline is added in an open label fashion. It is hypothesized that those patients receiving combination therapy will last 3 months with follow-up tracking lasting 1 year.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-07-03
• Study First Submitted QC: 2001-07-04
• Study First Posted: 2001-07-05
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-21
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Age > 55
• Current depressive syndrome
• Current alcohol dependence
• No psychosis
• No opioid or cocaine abuse or dependence

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	NALTREXONE	Naltrexone

Primary Outcome Measures

Name	Time	Method
Alcohol use'	12 weeks

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States