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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
Sponsor:
Collaborators:
STRONG STAR Multidisciplinary PTSD Research Consortium
South Texas Veterans Health Care System
U.S. Army Medical Research and Development Command
United States Department of Defense
Information provided by (Responsible Party):
John Roache, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions PTSD
Alcohol Use Disorder
Interventions Drug: Sertraline
Drug: Placebo
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description

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.

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

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.

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

Period Title: Overall Study
Started 26 23
Completed 14 13
Not Completed 12 10
Arm/Group Title Sertraline Placebo Total
Hide Arm/Group Description

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.

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

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 26 23 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 49 participants
39.9  (13.4) 41.2  (12.2) 40.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
Female
1
   3.8%
2
   8.7%
3
   6.1%
Male
25
  96.2%
21
  91.3%
46
  93.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
Hispanic or Latino
19
  73.1%
9
  39.1%
28
  57.1%
Not Hispanic or Latino
7
  26.9%
14
  60.9%
21
  42.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.7%
5
  21.7%
7
  14.3%
White
19
  73.1%
14
  60.9%
33
  67.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  19.2%
4
  17.4%
9
  18.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 23 participants 49 participants
26 23 49
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 23 participants 49 participants
26 23 49
1.Primary Outcome
Title Percent Heavy Drinking Days
Hide Description Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:

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.

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

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.

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

Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: percentage of days
55.5  (24.8) 65.1  (24.1)
2.Secondary Outcome
Title PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)
Hide Description

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

  1. A little bit
  2. Moderately
  3. Quite a bit
  4. 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.

Time Frame 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:

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.

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

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.

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

Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
59.6  (9.6) 61.7  (11.6)
Time Frame From baseline to 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description

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.

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

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.

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

All-Cause Mortality
Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/26 (88.46%)      18/23 (78.26%)    
Gastrointestinal disorders     
Diarrhea   7/26 (26.92%)  7 3/23 (13.04%)  3
Nausea   6/26 (23.08%)  6 4/23 (17.39%)  4
General disorders     
Nightmares   5/26 (19.23%)  5 5/23 (21.74%)  5
Fatigue   5/26 (19.23%)  5 5/23 (21.74%)  5
Musculoskeletal and connective tissue disorders     
Muscle Spasm   3/26 (11.54%)  3 0/23 (0.00%)  0
Nervous system disorders     
Anxiety   5/26 (19.23%)  5 2/23 (8.70%)  2
Anger, hostility   4/26 (15.38%)  4 0/23 (0.00%)  0
Depression   5/26 (19.23%)  5 4/23 (17.39%)  4
Drowsiness, dizziness   2/26 (7.69%)  2 3/23 (13.04%)  3
Insomnia   6/26 (23.08%)  6 3/23 (13.04%)  3
Pain   8/26 (30.77%)  8 14/23 (60.87%)  14
Difficulty concentrating   2/26 (7.69%)  2 0/23 (0.00%)  0
Headache   8/26 (30.77%)  8 0/23 (0.00%)  0
Irritability   2/26 (7.69%)  2 0/23 (0.00%)  0
Reproductive system and breast disorders     
Sexual dysfunction   6/26 (23.08%)  6 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cold symptoms   4/26 (15.38%)  4 8/23 (34.78%)  8
Flu symptoms   2/26 (7.69%)  2 4/23 (17.39%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Roache
Organization: UT Health San Antonio
Phone: 210-562-5406
EMail: roache@uthscsa.edu
Layout table for additonal information
Responsible Party: John Roache, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02504931    
Other Study ID Numbers: W81XWH0820117
First Submitted: July 16, 2013
First Posted: July 22, 2015
Results First Submitted: December 21, 2017
Results First Posted: February 27, 2018
Last Update Posted: April 10, 2018