Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborators:
South Texas Veterans Health Care System STRONG STAR Multidisciplinary PTSD Research Consortium U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command United States Department of Defense