Trial Outcomes & Findings for Combined Treatment for Alcohol-Dependent Individuals With PTSD (NCT NCT00262223)
NCT ID: NCT00262223
Last Updated: 2020-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up
Results posted on
2020-03-03
Participant Flow
Participants in the metropolitan New York area were recruited through newspaper and radio advertisements, flyers, and referrals from outpatient mental health centers between April 2006 and March 2012.
Individuals were screened through a brief telephone interview and then completed a baseline interview. After baseline assessment and medical clearance, eligible participants began a one-week, single-blind placebo lead-in phase. Those who completed the lead in phase were accepted into the study.
Participant milestones
| Measure |
1) Seeking Safety + Sertraline
Seeking Safety + Sertraline
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
2) Seeking Safety + Placebo
Seeking Safety + Placebo;
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
|---|---|---|
|
Treatment Phase
STARTED
|
32
|
37
|
|
Treatment Phase
COMPLETED
|
28
|
29
|
|
Treatment Phase
NOT COMPLETED
|
4
|
8
|
|
1-week Post-treatment Follow-up
STARTED
|
28
|
29
|
|
1-week Post-treatment Follow-up
COMPLETED
|
24
|
25
|
|
1-week Post-treatment Follow-up
NOT COMPLETED
|
4
|
4
|
|
6-month Post-treatment Follow-up
STARTED
|
28
|
29
|
|
6-month Post-treatment Follow-up
COMPLETED
|
22
|
28
|
|
6-month Post-treatment Follow-up
NOT COMPLETED
|
6
|
1
|
|
12-month Post-treatment Follow-up
STARTED
|
28
|
29
|
|
12-month Post-treatment Follow-up
COMPLETED
|
21
|
22
|
|
12-month Post-treatment Follow-up
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
1) Seeking Safety + Sertraline
Seeking Safety + Sertraline
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
2) Seeking Safety + Placebo
Seeking Safety + Placebo;
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
3
|
6
|
|
Treatment Phase
Adverse Event
|
1
|
2
|
|
1-week Post-treatment Follow-up
Lost to Follow-up
|
4
|
4
|
|
6-month Post-treatment Follow-up
Lost to Follow-up
|
6
|
1
|
|
12-month Post-treatment Follow-up
Lost to Follow-up
|
7
|
7
|
Baseline Characteristics
Combined Treatment for Alcohol-Dependent Individuals With PTSD
Baseline characteristics by cohort
| Measure |
1) Seeking Safety + Sertraline
n=32 Participants
Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
2) Seeking Safety + Placebo
n=37 Participants
Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-upOutcome measures
| Measure |
1) Seeking Safety + Sertraline
n=32 Participants
Seeking Safety + Sertraline
|
2) Seeking Safety + Placebo
n=37 Participants
Seeking Safety + Placebo
|
|---|---|---|
|
Heavy Drinking Days/Week
Baseline
|
3.13 Days/Week
Standard Deviation 2.17
|
2.89 Days/Week
Standard Deviation 2.35
|
|
Heavy Drinking Days/Week
End-of-treatment
|
1.05 Days/Week
Standard Deviation 1.79
|
0.48 Days/Week
Standard Deviation 1.69
|
|
Heavy Drinking Days/Week
6-month
|
.86 Days/Week
Standard Deviation 1.46
|
0.75 Days/Week
Standard Deviation 1.53
|
|
Heavy Drinking Days/Week
12-month
|
0.30 Days/Week
Standard Deviation 0.47
|
0.24 Days/Week
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-upClinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and \>80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).
Outcome measures
| Measure |
1) Seeking Safety + Sertraline
n=32 Participants
Seeking Safety + Sertraline
|
2) Seeking Safety + Placebo
n=37 Participants
Seeking Safety + Placebo
|
|---|---|---|
|
PTSD Symptom Severity / Clinician Administered PTSD Scale
Baseline
|
65.50 units on a scale
Standard Deviation 20.03
|
59.50 units on a scale
Standard Deviation 18.97
|
|
PTSD Symptom Severity / Clinician Administered PTSD Scale
End-of-treatment
|
36.25 units on a scale
Standard Deviation 28.23
|
41.88 units on a scale
Standard Deviation 29.30
|
|
PTSD Symptom Severity / Clinician Administered PTSD Scale
6-month
|
30.09 units on a scale
Standard Deviation 20.70
|
37.46 units on a scale
Standard Deviation 25.88
|
|
PTSD Symptom Severity / Clinician Administered PTSD Scale
12-month
|
24.90 units on a scale
Standard Deviation 19.95
|
31.82 units on a scale
Standard Deviation 24.44
|
Adverse Events
Seeking Safety + Sertraline
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Seeking Seeking + Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seeking Safety + Sertraline
n=32 participants at risk
Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
|
Seeking Seeking + Placebo
n=37 participants at risk
Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
|
|---|---|---|
|
General disorders
Serious medical illness
|
3.1%
1/32
|
5.4%
2/37
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place