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

Alcohol Use Disorder Clinical Trial

— DDx  

Official title:

SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504931
• Other study ID #: W81XWH0820117
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2013
• Last updated: March 13, 2018
• Start date: April 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	South Texas Veterans Health Care System	San Antonio	Texas

Sponsors (5)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	South Texas Veterans Health Care System, STRONG STAR Multidisciplinary PTSD Research Consortium, U.S. Army Medical Research and Materiel Command, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)	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; Moderately; Quite a bit; 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.	12 weeks of treatment