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

• ClinicalTrials.gov Identifier: NCT02504931
• Recruitment Status: Completed
• First Posted: July 22, 2015
• Results First Posted: February 27, 2018
• Last Update Posted: April 10, 2018
• Sponsor: The University of Texas Health Science Center at San Antonio
• 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
• Information provided by (Responsible Party): John Roache, The University of Texas Health Science Center at San Antonio

Tracking Information

• First Submitted Date: July 16, 2013
• First Posted Date: July 22, 2015
• Results First Submitted Date: December 21, 2017
• Results First Posted Date: February 27, 2018
• Last Update Posted Date: April 10, 2018
• Actual Study Start Date: April 2011
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2018)

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.

• Original Primary Outcome Measures (submitted: July 21, 2015): Percent Heavy Drinking Days [ Time Frame: Subjects will be evaluated at final end-point outcomes determined after 12 weeks of treatment. ]

Current Secondary Outcome Measures (submitted: February 2, 2018)

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

1. A little bit
2. Moderately
3. Quite a bit
4. 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.

• Original Secondary Outcome Measures (submitted: July 21, 2015): PTSD symptom score from PCL [ Time Frame: Subjects will be evaluated at final end-point outcomes determined after 12 weeks of treatment ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
• Official Title: SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis
• 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• PTSD
• Alcohol Use Disorder

Intervention

• Drug: Sertraline
  A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.
  Other Name: Zoloft
• Drug: Placebo
  A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm.
  Other Name: Placebo Control

Study Arms

• Experimental: Sertraline

  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.

  Intervention: Drug: Sertraline
• Placebo Comparator: Placebo

  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.

  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2018): 49
• Original Estimated Enrollment (submitted: July 21, 2015): 100
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02504931
• Other Study ID Numbers: W81XWH0820117
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: John Roache, The University of Texas Health Science Center at San Antonio
• Study Sponsor: The University of Texas Health Science Center at San Antonio

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

Investigators

• Principal Investigator: John D Roache, PhD; The University of Texas Health Science Center at San Antonio

• PRS Account: The University of Texas Health Science Center at San Antonio
• Verification Date: April 2017