Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | April 2011 |
| End Date: | December 2016 |
SSRI Treatment of Dual Diagnosis PTSD and Alcohol Dependence: A Test of the Serotonergic Hypothesis
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
