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Treating Alcohol Use In Older Adults With Depression

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018824
First received: July 3, 2001
Last updated: September 21, 2009
Last verified: September 2009
History of Changes
  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 4

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:

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:

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 May 16, 2013