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

Completed · Phase 4 · Has a placebo group

Conditions studied: PTSD, Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT02504931

Run by

The University of Texas Health Science Center at San Antonio

People needed

49

Starts

2011-04-01

Expected to finish

2016-12-01

Last updated by the study team

2018-04-10

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21-65 year old Veterans with PTSD who regularly drink more than 5 standard drinks of alcohol in a day
• who experienced a trauma during deployment and
• who regularly drink more than 5 standard drinks alcohol and
• are interested in coming in once per week for 12 weeks of dual diagnosis individual therapy and
• are willing to participate in a placebo-controlled trial which could include receipt of sertraline (Zoloft).

You may not qualify if…

• if their PTSD Symptoms are adequately controlled by other medication regimens;
• they require inpatient alcohol detoxification; or currently receive naltrexone, disulfiram, acamprosate, or ondansetron treatment for alcohol dependence; or
• currently have an unstable medical illness; or
• have a bipolar or psychotic disorder; or
• currently are taking and are unwilling to discontinue taking any SSRI, SNRI, MAO inhibitor, tricyclic antidepressant, or anticonvulsant.

Where it is running

• South Texas Veterans Health Care System — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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