Trial Outcomes & Findings for Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD). (NCT NCT00744055)
NCT ID: NCT00744055
Last Updated: 2020-03-19
Results Overview
Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
96 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-03-19
Participant Flow
Randomization was conducted by the pharmacy using a 1:1 randomization in blocks of 4 and stratified by site, gender. Completers were defined as subjects for whom we had complete data at the end of the treatment period (week 12) whether they remained on medication or not.
Participant milestones
| Measure |
Prazosin
prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day
|
Placebo
Placebo in identical looking capsule blister packs
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
46
|
|
Overall Study
COMPLETED
|
43
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
Reasons for withdrawal
| Measure |
Prazosin
prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day
|
Placebo
Placebo in identical looking capsule blister packs
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).
Baseline characteristics by cohort
| Measure |
Prazosin
n=50 Participants
men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
|
Placebo
n=46 Participants
men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
43.40 years
STANDARD_DEVIATION 12.95 • n=4 Participants
|
43.96 years
STANDARD_DEVIATION 12.96 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 participants
n=93 Participants
|
38 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
10 participants
n=93 Participants
|
8 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
PTSD Symptoms
|
71.86 units on a scale
STANDARD_DEVIATION 20.32 • n=93 Participants
|
75.86 units on a scale
STANDARD_DEVIATION 14.44 • n=4 Participants
|
73.7 units on a scale
STANDARD_DEVIATION 17.86 • n=27 Participants
|
|
Average Drinks Per Drinking Day
|
17.33 drinks per day
STANDARD_DEVIATION 10.73 • n=93 Participants
|
21.90 drinks per day
STANDARD_DEVIATION 13.24 • n=4 Participants
|
19.53 drinks per day
STANDARD_DEVIATION 8.21 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksUsing the Timeline Follow Back method, a calendar method for assessing drug and alcohol use
Outcome measures
| Measure |
Prazosin
n=50 Participants
prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day
|
Placebo
n=46 Participants
Placebo in identical looking capsule blister packs
Placebo
|
|---|---|---|
|
Number of Drinking Days
|
11.04 days
Standard Deviation 18.86
|
9.21 days
Standard Deviation 16.64
|
PRIMARY outcome
Timeframe: 12 weeksClinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD \>80=Extreme PTSD
Outcome measures
| Measure |
Prazosin
n=50 Participants
prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day
|
Placebo
n=46 Participants
Placebo in identical looking capsule blister packs
Placebo
|
|---|---|---|
|
Clinician-Administered PTSD Scale
|
37.94 units on a scale
Standard Deviation 37.62
|
37.93 units on a scale
Standard Deviation 41.13
|
Adverse Events
Prazosin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prazosin
n=50 participants at risk
prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day
|
Placebo
n=46 participants at risk
Placebo in identical looking capsule blister packs
Placebo
|
|---|---|---|
|
Psychiatric disorders
Alcohol Relapse
|
10.0%
5/50 • 12 weeks
|
15.2%
7/46 • 12 weeks
|
|
Psychiatric disorders
Homocidal Ideation
|
0.00%
0/50 • 12 weeks
|
2.2%
1/46 • 12 weeks
|
|
Vascular disorders
Partial thrombus
|
2.0%
1/50 • 12 weeks
|
0.00%
0/46 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
2.0%
1/50 • 12 weeks
|
0.00%
0/46 • 12 weeks
|
|
Gastrointestinal disorders
Appendicitis
|
2.0%
1/50 • 12 weeks
|
0.00%
0/46 • 12 weeks
|
|
General disorders
Fainting
|
2.0%
1/50 • 12 weeks
|
0.00%
0/46 • 12 weeks
|
|
General disorders
Falling
|
4.0%
2/50 • 12 weeks
|
0.00%
0/46 • 12 weeks
|
Additional Information
Elizabeth Ralevski
Yale University School Of Medicine Department of Psychiatry
Phone: 2039325711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place