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

NCT02504931 | Completed Phase 4 Results DMC

• 1 other identifier: W81XWH0820117
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PTSD; Alcohol; Dual Diagnosis; Sertraline; SSRI

Outcome Measures

Primary Outcomes (1)

• Percent Heavy Drinking Days

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks of treatment

Study Arms (2)

Sertraline

EXPERIMENTAL

Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort. Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

Matching placebo capsules will be filled with corn starch only on the same schedule as the Sertraline. Subjects in the Placebo arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.

Drug: Placebo

Interventions

Sertraline DRUG

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

Also known as: Zoloft

Sertraline

Placebo DRUG

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

Also known as: Placebo Control

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• STRONG STAR Multidisciplinary PTSD Research Consortium: collaborator
• South Texas Veterans Health Care System: collaborator
• U.S. Army Medical Research and Development Command: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. John Roache
• Organization: UT Health San Antonio

roache@uthscsa.edu

210-562-5406

Study Officials

• John D Roache, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 22, 2015
• Study Start: April 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 10, 2018
• Results First Posted: February 27, 2018

Record last verified: 2017-04

Locations

US (1)