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Completed

NCT Number: NCT02504931

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

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.

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Key information

Conditions

PTSD Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

About this study

Experimental Design. The study design is a parallel group, double-blind, placebo-controlled, stratified, randomized medication treatment trial of male and female veterans who experienced "in-theater" trauma and have both a PTSD and Alcohol Use dual diagnosis. All subjects will receive 12 weeks of manualized cognitive & behavioral therapy as a standard of care. Additionally, subjects will be randomized 1:1 to receive double-blind treatment with Sertraline vs. Placebo as an adjunctive treatment. The manualized therapy provides standard cognitive-behavioral therapy (CBT) addressing alcohol use and prolonged exposure (PE) behavioral therapy targeting PTSD. Sertraline is a common treatment for PTSD and psychiatric disturbance but is hypothesized to have differential efficacy in different subtypes of alcohol drinking patients. A stratified randomization scheme will balance placebo and sertraline assignment to two groups, and a post-hoc clustering approach will be used to determine which subgroups of dual diagnosis patients may benefit from sertraline vs. placebo treatment.

Veterans with PTSD who regularly drink more than 5 standard drinks of alcohol in a day (note one 12oz beer = one standard drink) may be eligible for the study if they meet criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Sertraline

Drug

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

Other names: Zoloft

Placebo

Drug

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

Other names: Placebo Control

Primary outcomes

  1. Percent Heavy Drinking Days

    Time frame: 12 weeks

    Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.

Secondary outcomes

  1. PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)

    Time frame: 12 weeks of treatment

    The PCL is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.

    The survey has 20 questions scored as:

    0=Not at all

    • A little bit
    • Moderately
    • Quite a bit
    • Extremely

    Interpretation of the PCL should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items to give a total of 1-80 points. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • STRONG STAR Multidisciplinary PTSD Research Consortium
  • South Texas Veterans Health Care System
  • U.S. Army Medical Research and Development Command
  • United States Department of Defense

Registry information

Official study title

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

Acronym: DDx

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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