Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004554
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2000-02-04
Brief Title:
Sertraline for Alcohol Dependence and Depression
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Sertraline for Alcohol Dependence and Depression
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine depressed alcoholic outpatients to assess whether combining naltrexone Revia and sertraline Zoloft will result in greater reductions in both drinking and depression over either medication alone or placebo A secondary aim is to determine whether certain patient features will predict response to sertraline naltrexone or the combination of the two drugs Subjects will be randomized into treatment groups for 14 weeks The followup phase includes two visits at 6 and 9 months after treatment
Detailed Description:
The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind placebo-controlled combination of 100 mgday of naltrexone 200 mgday of sertraline and individual cognitive behavioral therapy CBT For testing the medication the design will be 2x2 consisting of four groups naltrexonesertraline naltrexone only sertraline only placebo All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None