Treating Alcohol Use In Older Adults With Depression
Primary Purpose
Alcoholism, Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NALTREXONE
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
Inclusion Criteria: Age > 55 Current depressive syndrome Current alcohol dependence No psychosis No opioid or cocaine abuse or dependence Exclusion Criteria:
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Naltrexone
Placebo
Outcomes
Primary Outcome Measures
Alcohol use'
Secondary Outcome Measures
Full Information
NCT ID
NCT00018824
First Posted
July 3, 2001
Last Updated
September 21, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00018824
Brief Title
Treating Alcohol Use In Older Adults With Depression
Official Title
The Treatment of Late Life Major Depression Complication by Alcohol
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Naltrexone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
NALTREXONE
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Alcohol use'
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 55
Current depressive syndrome
Current alcohol dependence
No psychosis
No opioid or cocaine abuse or dependence
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Oslin, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15956269
Citation
Oslin DW. Treatment of late-life depression complicated by alcohol dependence. Am J Geriatr Psychiatry. 2005 Jun;13(6):491-500. doi: 10.1176/appi.ajgp.13.6.491.
Results Reference
result
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Treating Alcohol Use In Older Adults With Depression
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