Clinical trial NCT02504931: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PTSD
Alcohol Use Disorder
Keywords: PTSD
Alcohol
Dual Diagnosis
Sertraline
SSRI
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: STRONG STAR Multidisciplinary PTSD Research Consortium
name: South Texas Veterans Health Care System
name: U.S. Army Medical Research and Development Command
name: United States Department of Defense
First posted: 2015-07-22
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: 12 weeks
Secondary outcomes:
measure: PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)
timeFrame: 12 weeks of treatment
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: John D Roache, PhD
role: PRINCIPAL_INVESTIGATOR
References: