Treating Alcohol Use In Older Adults With Depression - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018824

Purpose

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

Condition	Intervention	Phase
Alcoholism Depression	Drug: NALTREXONE Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Treatment of Late Life Major Depression Complication by Alcohol

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism Depression

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Alcohol use` [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	October 1999
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Naltrexone	Drug: NALTREXONE
Placebo Comparator: 2 Placebo	Drug: Placebo

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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018824

Locations

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

David W. Oslin, MD

University of Pennsylvania

More Information

Publications:

Oslin DW. Treatment of late-life depression complicated by alcohol dependence. Am J Geriatr Psychiatry. 2005 Jun;13(6):491-500.

Responsible Party:	Oslin, David - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018824 History of Changes
Other Study ID Numbers:	MHBS-009-98S
Study First Received:	July 3, 2001
Last Updated:	September 21, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Depression
Depressive Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012