Treating Alcohol Use In Older Adults With Depression
Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00018824
Collaborator
(none)
74
1
2
63
1.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Interventional
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
:
Oct 1, 1999
Actual Primary Completion Date
:
Jan 1, 2005
Actual Study Completion Date
:
Jan 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Naltrexone |
Drug: NALTREXONE
|
| Placebo Comparator: 2 Placebo |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Alcohol use' [12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age > 55
-
Current depressive syndrome
-
Current alcohol dependence
-
No psychosis
-
No opioid or cocaine abuse or dependence
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Principal Investigator: David W. Oslin, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00018824
Other Study ID Numbers:
- MHBS-009-98S
First Posted:
Jul 5, 2001
Last Update Posted:
Sep 23, 2009
Last Verified:
Sep 1, 2009