Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems (DDx)
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|ClinicalTrials.gov Identifier: NCT02504931|
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : February 27, 2018
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|PTSD Alcohol Use Disorder||Drug: Sertraline Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis|
|Actual Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||December 2016|
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.
A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.
Other Name: Zoloft
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.
A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm.
Other Name: Placebo Control
- 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.
- 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
- Quite a bit
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504931
|United States, Texas|
|South Texas Veterans Health Care System|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||John D Roache, PhD||The University of Texas Health Science Center at San Antonio|