Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: PTSD; Alcohol Use Disorder
Intervention: Sertraline (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: The University of Texas Health Science Center at San Antonio Official(s) and/or principal investigator(s): John D Roache, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio
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.
Clinical Details
Official title: SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percent Heavy Drinking Days
Secondary outcome: PTSD symptom score from PCL
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
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
South Texas Veterans Health Care System, San Antonio, Texas 78229, United States
Additional Information
Starting date: April 2011
Last updated: July 21, 2015
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