Trial Outcomes & Findings for Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems (NCT NCT02504931)
NCT ID: NCT02504931
Last Updated: 2018-04-10
Results Overview
Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-04-10
Participant Flow
Participant milestones
| Measure |
Sertraline
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.
|
Placebo
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 Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
Baseline characteristics by cohort
| Measure |
Sertraline
n=26 Participants
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.
|
Placebo
n=23 Participants
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
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.
Outcome measures
| Measure |
Sertraline
n=26 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Percent Heavy Drinking Days
|
55.5 percentage of days
Standard Deviation 24.8
|
65.1 percentage of days
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentThe 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.
Outcome measures
| Measure |
Sertraline
n=26 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)
|
59.6 Units on a scale
Standard Deviation 9.6
|
61.7 Units on a scale
Standard Deviation 11.6
|
Adverse Events
Sertraline
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sertraline
n=26 participants at risk
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.
|
Placebo
n=23 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
19.2%
5/26 • Number of events 5 • From baseline to 12 weeks.
|
8.7%
2/23 • Number of events 2 • From baseline to 12 weeks.
|
|
Nervous system disorders
Anger, hostility
|
15.4%
4/26 • Number of events 4 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
15.4%
4/26 • Number of events 4 • From baseline to 12 weeks.
|
34.8%
8/23 • Number of events 8 • From baseline to 12 weeks.
|
|
Nervous system disorders
Depression
|
19.2%
5/26 • Number of events 5 • From baseline to 12 weeks.
|
17.4%
4/23 • Number of events 4 • From baseline to 12 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
7/26 • Number of events 7 • From baseline to 12 weeks.
|
13.0%
3/23 • Number of events 3 • From baseline to 12 weeks.
|
|
Nervous system disorders
Drowsiness, dizziness
|
7.7%
2/26 • Number of events 2 • From baseline to 12 weeks.
|
13.0%
3/23 • Number of events 3 • From baseline to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Flu symptoms
|
7.7%
2/26 • Number of events 2 • From baseline to 12 weeks.
|
17.4%
4/23 • Number of events 4 • From baseline to 12 weeks.
|
|
Nervous system disorders
Insomnia
|
23.1%
6/26 • Number of events 6 • From baseline to 12 weeks.
|
13.0%
3/23 • Number of events 3 • From baseline to 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
6/26 • Number of events 6 • From baseline to 12 weeks.
|
17.4%
4/23 • Number of events 4 • From baseline to 12 weeks.
|
|
General disorders
Nightmares
|
19.2%
5/26 • Number of events 5 • From baseline to 12 weeks.
|
21.7%
5/23 • Number of events 5 • From baseline to 12 weeks.
|
|
Nervous system disorders
Pain
|
30.8%
8/26 • Number of events 8 • From baseline to 12 weeks.
|
60.9%
14/23 • Number of events 14 • From baseline to 12 weeks.
|
|
Nervous system disorders
Difficulty concentrating
|
7.7%
2/26 • Number of events 2 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
|
General disorders
Fatigue
|
19.2%
5/26 • Number of events 5 • From baseline to 12 weeks.
|
21.7%
5/23 • Number of events 5 • From baseline to 12 weeks.
|
|
Nervous system disorders
Headache
|
30.8%
8/26 • Number of events 8 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
|
Nervous system disorders
Irritability
|
7.7%
2/26 • Number of events 2 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
11.5%
3/26 • Number of events 3 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
23.1%
6/26 • Number of events 6 • From baseline to 12 weeks.
|
0.00%
0/23 • From baseline to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place