CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02504931
NCT02504931Phase 4Completed

SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis

The University of Texas Health Science Center at San Antonio·interventional·Posted Jul 22, 2015·Updated Apr 10, 2018

In Brief

A Phase 4 clinical trial evaluating Sertraline and Placebo for PTSD and Alcohol Use Disorder. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The investigators propose to conduct a clinical trial to evaluate sertraline treatment efficacy in a large sample of military veterans with a dual diagnosis of PTSD and Alcohol Use Disorder who are receiving Cognitive and Behavioral Therapy as part of the VA-system's new dual diagnosis program. The study is designed as an efficacy trial of sertraline used as an adjunct to Cognitive Behavioral Therapy (CBT) in the treatment of PTSD/Alcohol dual diagnosis. There are two outcomes of interest, namely PTSD symptom improvement and also decreased alcohol consumption. The investigators are interested to know whether or not sertraline is superior to placebo in improving the symptoms of either one or both of these two disorders. Even though sertraline is a treatment of choice for PTSD, the investigators expect that the comorbid condition of alcohol dependence will complicate the treatment of PTSD and that the clustered subgroups will show differential treatment response with sertraline. The primary objective of the present study is to identify subgroups of alcohol dependent persons with PTSD who will either benefit or not benefit from treatment with SSRI's. The proposed study will enroll veterans with PTSD and dually-diagnosed alcohol dependence in a 12-week treatment providing sertraline vs. placebo medication as an adjunct to manualized CBT and will specifically test the hypothesis that subtypes of alcohol dependence can be used to predict which patients respond well and which subgroup responds poorly to SSRI treatment.

Study Details

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.9 years ago

Interventions

Sertralinedrug

A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.

Placebodrug

A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm.