Trial Outcomes & Findings for Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder (NCT NCT01518972)
NCT ID: NCT01518972
Last Updated: 2020-08-25
Results Overview
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group.
COMPLETED
PHASE2
30 participants
6 weeks
2020-08-25
Participant Flow
Participant were recruited from September 2009 to June 2012 (2 years and 9 months). Out of 354 people who inquired about the study, 30 were eligible and randomized.
Out of 354 individuals who inquired about the study, 54 consented and completed the in-person screen. Out of these 54 individuals, 2 declined participation and 22 were ineligible: 10 individuals did not have PTSD and the rest had an acute illness (4), uncontrolled psychosis (2), legal involvement (2), and other reasons not previously mentioned (4).
Participant milestones
| Measure |
Prazosin
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Prazosin
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Moved from area
|
1
|
0
|
|
Overall Study
Transportation problems
|
1
|
0
|
|
Overall Study
Exclusionary medical condition
|
1
|
0
|
|
Overall Study
Missed safety visits
|
0
|
1
|
|
Overall Study
Exclusionary medication
|
0
|
1
|
|
Overall Study
Declined medication starting on day 12
|
0
|
1
|
Baseline Characteristics
Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Prazosin
n=15 Participants
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
n=15 Participants
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of Drinks per Day, 90 Days Prior to Baseline
|
11 drinks per day
STANDARD_DEVIATION 10.8 • n=5 Participants
|
8.5 drinks per day
STANDARD_DEVIATION 5.1 • n=7 Participants
|
9.75 drinks per day
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Total Drinks, 7 Days Prior to Baseline
|
80.1 total drinks per week
STANDARD_DEVIATION 75.1 • n=5 Participants
|
49.6 total drinks per week
STANDARD_DEVIATION 44.6 • n=7 Participants
|
64.85 total drinks per week
STANDARD_DEVIATION 62.6 • n=5 Participants
|
|
Number of Drinking Days, 7 Days Prior to Baseline
|
5.1 drinking days per week
STANDARD_DEVIATION 1.7 • n=5 Participants
|
4.2 drinking days per week
STANDARD_DEVIATION 2.8 • n=7 Participants
|
4.65 drinking days per week
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Baseline Alcohol Craving Score
|
22.1 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
19.8 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Baseline PTSD (Post-Traumatic Stress Disorder) Score
|
31.5 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
31.6 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
31.55 units on a scale
STANDARD_DEVIATION 8.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Percent drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable.
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group.
Outcome measures
| Measure |
Prazosin
n=9 Participants
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
n=11 Participants
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
Percent Drinking Days Per Week
|
18.1 percentage of drinking days per week
Interval -1.1 to 37.4
|
49.3 percentage of drinking days per week
Interval 31.7 to 66.9
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Percent heavy drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable.
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. Heavy drinking was defined as 5 or more drinks per day for men and 4 or more drinks per day for women. The percentage of heavy drinking days of each participant was calculated by summing the number of heavy drinking days and comparing them with the total number of drinking days in the same week. The percentage of heavy drinking days from each week was added and averaged to get the percentage of heavy drinking days per week per participant. The percentage of heavy drinking days of all participants in the Prazosin group was added and averaged to get the mean of percentage of weekly heavy drinking days of the Prazosin group. These steps were repeated for the Placebo group.
Outcome measures
| Measure |
Prazosin
n=9 Participants
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
n=11 Participants
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
Percent Heavy Drinking Days Per Week
|
3.7 Percentage of heavy drinking days/week
Interval -14.4 to 21.8
|
27.4 Percentage of heavy drinking days/week
Interval 11.3 to 43.5
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The total number of drinks per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable.
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The weekly total drinks of each participant were calculated by adding the number of drinks by week. The total drinks from each week were added and averaged to get the weekly total drinks of each participant. The weekly total drinks of all participants in the Prazosin group were added and averaged to get the total drinks per week for the Prazosin group. These steps were repeated for the Placebo group.
Outcome measures
| Measure |
Prazosin
n=9 Participants
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
n=11 Participants
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
Total Drinks Per Week
|
7.9 drinks per week
Interval -15.7 to 31.4
|
27 drinks per week
Interval 5.9 to 48.1
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: PTSD outcomes between weeks 1 and 6 were analyzed using multilevel mixed-effects linear regression models. Models were adjusted for baseline PTSD severity as measured by corresponding PSS-I scores \& sub-scores because measures comparable to the IVR PTSD measures were not available at baseline. Analyses were also adjusted for gender.
PTSD symptoms/changes in PTSD (Post-Traumatic Stress Disorder) symptomatology was calculated using data from the IVR (interactive Voice Response) monitoring. PTSD scores were derived by computing the daily average of the item totals for overall PTSD and the symptom clusters. The rating range was 0 (not at all) to 8 (extremely). The higher the score/rating, the more severe the PTSD symptoms. The lowest and highest possible average are 0 and 8, respectively.
Outcome measures
| Measure |
Prazosin
n=9 Participants
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Placebo
n=11 Participants
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
PTSD Symptom Assessments
Avoidance/numbing
|
2.9 units on a scale
Interval 1.6 to 4.2
|
2.4 units on a scale
Interval 1.2 to 3.6
|
|
PTSD Symptom Assessments
Total PTSD score
|
3.1 units on a scale
Interval 1.9 to 4.2
|
2.5 units on a scale
Interval 1.4 to 3.6
|
|
PTSD Symptom Assessments
Re-experiencing
|
3.2 units on a scale
Interval 1.9 to 4.4
|
2.6 units on a scale
Interval 1.4 to 3.8
|
|
PTSD Symptom Assessments
Hypervigilance
|
3.2 units on a scale
Interval 2.0 to 4.4
|
2.4 units on a scale
Interval 1.3 to 3.6
|
|
PTSD Symptom Assessments
Disturbung dreams
|
2.5 units on a scale
Interval 1.0 to 3.9
|
2.8 units on a scale
Interval 1.5 to 4.1
|
Adverse Events
Placebo
Prazosin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo medication
Placebo medication: Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
Prazosin
n=14 participants at risk
Prazosin medication
Prazosin: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
|
|---|---|---|
|
General disorders
Experienced 1 adverse event
|
14.3%
2/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
0.00%
0/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
|
General disorders
Experienced 2 adverse events
|
35.7%
5/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
7.1%
1/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
|
General disorders
Experienced 3 adverse events
|
50.0%
7/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
64.3%
9/14 • The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not.
Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), \& weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's.
|
Additional Information
Tracy L. Simpson, Ph.D.
VA Puget Sound Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place