Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems

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.

Conditions

• PTSD
• Alcohol Use Disorder

Interventions

DRUG

Sertraline

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

DRUG

Placebo

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

Sponsors & Collaborators

• STRONG STAR Multidisciplinary PTSD Research Consortium

  collaborator UNKNOWN

• South Texas Veterans Health Care System

  collaborator FED

• U.S. Army Medical Research and Development Command

  collaborator FED

• United States Department of Defense

  collaborator FED

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• John D Roache, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2016-08-31

Completion

2016-12-31

Countries

• United States

Study Locations