Trial Outcomes & Findings for Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment (NCT NCT02966340)
NCT ID: NCT02966340
Last Updated: 2019-05-28
Results Overview
The unpredictable shock and predictable shock startle response potentiation (vs. no shock) during the administration of the NPU stressor task. Values represent point estimate of effect from unadjusted general linear model analyses with 95% confidence intervals
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
7 days
Results posted on
2019-05-28
Participant Flow
In order to enroll 64 participants with valid data, 70 participants were randomized to account for 4 lost early in study flow (one data collection error, two startle non-responders, and one withdrawn after visit 1).
Participant milestones
| Measure |
Prazosin 1st Visit, Placebo 2nd Visit
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
Placebo 1st Visit, Prazosin 2nd Visit
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
33
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Prazosin 1st Visit, Placebo 2nd Visit
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
Placebo 1st Visit, Prazosin 2nd Visit
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
data acquisition error
|
1
|
0
|
|
Overall Study
startle non-responder
|
1
|
1
|
Baseline Characteristics
Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment
Baseline characteristics by cohort
| Measure |
All Participants Who Completed the Study
n=64 Participants
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Results are to be reported by treatment (placebo vs prazosin) each of which include results for all participants. Therefore we report baseline characteristics for the entire group.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe unpredictable shock and predictable shock startle response potentiation (vs. no shock) during the administration of the NPU stressor task. Values represent point estimate of effect from unadjusted general linear model analyses with 95% confidence intervals
Outcome measures
| Measure |
Prazosin 2mg Trials
n=64 Participants
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
Placebo Trials
n=64 Participants
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
|---|---|---|
|
Startle Potentiation During Stress Reactivity Task.
Predictable Shock
|
45.7 startle potentiation (μV)
Interval 33.5 to 57.8
|
40.1 startle potentiation (μV)
Interval 29.7 to 50.4
|
|
Startle Potentiation During Stress Reactivity Task.
Unpredictable Shock
|
33.2 startle potentiation (μV)
Interval 24.3 to 42.1
|
25.2 startle potentiation (μV)
Interval 16.6 to 33.8
|
SECONDARY outcome
Timeframe: 7 daysAfter the No-shock, Predictable-shock, Unpredictable-shock (NPU) task participants retrospectively reported their anxiety/fear during each condition on a 5-point likert scale (1 = 'Not at all anxious/ fearful', 5 = 'Very anxious/fearful'). The startle response is a defensive reflex that is elicited by an auditory stimuli (e.g., 50ms white noise) and measured via eyeblink electromyogram (EMG) activity over the obicularis oculi muscle. Startle potentiation is calculated as the increase in startle during unpredictable and predictable stressors relative to a no-stressor condition in the NPU task. Outcome is anxiety potentiation during unpredictable shock and predictable shock (vs. no-shock) conditions. This was assessed with a single question, total possible range was 1-5.
Outcome measures
| Measure |
Prazosin 2mg Trials
n=64 Participants
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
Placebo Trials
n=64 Participants
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
|---|---|---|
|
Self-reported Anxiety Potentiation During Stress Reactivity Task.
Predictable Shock
|
2.0 units on a scale
Interval 1.7 to 2.3
|
2.1 units on a scale
Interval 1.8 to 2.4
|
|
Self-reported Anxiety Potentiation During Stress Reactivity Task.
Unpredictable Shock
|
2.3 units on a scale
Interval 2.0 to 2.6
|
2.4 units on a scale
Interval 2.1 to 2.7
|
Adverse Events
Prazosin 2mg Trials
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo Trials
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prazosin 2mg Trials
n=64 participants at risk
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
Placebo Trials
n=64 participants at risk
All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).
Prazosin: 2mg Prazosin
Placebo: Placebo
|
|---|---|---|
|
Vascular disorders
Dizzyness
|
25.0%
16/64 • Number of events 16 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
0.00%
0/64 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
|
Vascular disorders
Lightheadedness
|
18.8%
12/64 • Number of events 12 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
0.00%
0/64 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
6/64 • Number of events 6 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
0.00%
0/64 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
|
Vascular disorders
Headache
|
4.7%
3/64 • Number of events 3 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
1.6%
1/64 • Number of events 1 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
|
Vascular disorders
Drowsiness
|
6.2%
4/64 • Number of events 4 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
3.1%
2/64 • Number of events 2 • Up to 24 hours
Nurses completed Adverse Events (AE) evaluations at 1, 3, 4, 5, and 6 hours post-dose at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place