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Treating Alcohol Use In Older Adults With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00018824
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Alcoholism Depression Drug: NALTREXONE Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Late Life Major Depression Complication by Alcohol
Study Start Date : October 1999
Primary Completion Date : January 2005
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Naltrexone
Drug: NALTREXONE
Placebo Comparator: 2
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Alcohol use` [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018824


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David W. Oslin, MD University of Pennsylvania

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
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Depression
Depressive Disorder
Alcoholism
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents