Trial Outcomes & Findings for Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders (NCT NCT02322047)
NCT ID: NCT02322047
Last Updated: 2020-12-29
Results Overview
PDD was calculated based on self-reported drinking history collected via Form-90. Drinking days were defined as days when participants consumed alcohol. Form-90 was completed by participants in visit 2 (baseline) and visit 8 (last visit). Form-90 collected in the baseline visit recorded participants' alcohol consumption from 90 days prior to their baseline visit until the day before their baseline visit. Form-90 collected in the last visit recorded participants' alcohol consumption from baseline until the day before their last visit. This outcome measures changes in PDD between visit 8 and visit 2. Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days. The outliers were due to scheduling difficulties.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Visit 2 (baseline) and visit 8 (last visit). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days due to scheduling difficulties.
Results posted on
2020-12-29
Participant Flow
Recruitment was done from 03/03/2015 to 09/18/2018; however the last participant was recruited on 08/30/2018 because the rest of the interested individuals were not eligible. Participants were recruited primarily through letters that were sent to those whose medical records indicated they likely had an active Alcohol Use Disorder (AUD) and had not been prescribed the study medications. Other recruitment methods: flyers, VA TV monitors, and advertising in the local media.
Interested individuals called study staff and were screened for eligibility. Out of 200 phone screens, 97 individuals were eligible and invited to the screening visit. Of these, 21 did not show or were lost to follow up, 7 canceled their visit, and 8 declined the visit. Out of 61 individuals who came to screening, 31 were eligible and randomized.
Participant milestones
| Measure |
Praz/Nal
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Praz/Nal
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
Baseline characteristics by cohort
| Measure |
Praz/Nal
n=7 Participants
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 Participants
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 Participants
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=8 Participants
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
54.86 years
STANDARD_DEVIATION 9.08 • n=7 Participants
|
54.43 years
STANDARD_DEVIATION 6.19 • n=5 Participants
|
52.38 years
STANDARD_DEVIATION 10.72 • n=4 Participants
|
53.14 years
STANDARD_DEVIATION 9.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American/American Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Percent drinking days (PDD)
|
73.10 percentage of drinking days
STANDARD_DEVIATION 28.10 • n=5 Participants
|
87.93 percentage of drinking days
STANDARD_DEVIATION 19.87 • n=7 Participants
|
64.44 percentage of drinking days
STANDARD_DEVIATION 26.04 • n=5 Participants
|
75.83 percentage of drinking days
STANDARD_DEVIATION 21 • n=4 Participants
|
75.34 percentage of drinking days
STANDARD_DEVIATION 24.08 • n=21 Participants
|
|
Percent heavy drinking days (PHDD)
|
54.99 percentage of heavy drinking days
STANDARD_DEVIATION 37.18 • n=5 Participants
|
77.77 percentage of heavy drinking days
STANDARD_DEVIATION 28.63 • n=7 Participants
|
47.62 percentage of heavy drinking days
STANDARD_DEVIATION 34.51 • n=5 Participants
|
66.25 percentage of heavy drinking days
STANDARD_DEVIATION 33.60 • n=4 Participants
|
61.81 percentage of heavy drinking days
STANDARD_DEVIATION 33.77 • n=21 Participants
|
|
Alcohol craving
|
18.50 scores on scale
STANDARD_DEVIATION 3.89 • n=5 Participants
|
20.29 scores on scale
STANDARD_DEVIATION 6.68 • n=7 Participants
|
16.71 scores on scale
STANDARD_DEVIATION 5.59 • n=5 Participants
|
16.86 scores on scale
STANDARD_DEVIATION 5.76 • n=4 Participants
|
18.10 scores on scale
STANDARD_DEVIATION 5.41 • n=21 Participants
|
|
Mean drinks per day of drinking
|
8.17 drinks
STANDARD_DEVIATION 5.40 • n=5 Participants
|
11.88 drinks
STANDARD_DEVIATION 7.55 • n=7 Participants
|
8.44 drinks
STANDARD_DEVIATION 3.97 • n=5 Participants
|
13.88 drinks
STANDARD_DEVIATION 9.55 • n=4 Participants
|
10.70 drinks
STANDARD_DEVIATION 7.12 • n=21 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (baseline) and visit 8 (last visit). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days due to scheduling difficulties.Population: Only participants who completed the study or had an intention to treat (ITT) were included in analyses.
PDD was calculated based on self-reported drinking history collected via Form-90. Drinking days were defined as days when participants consumed alcohol. Form-90 was completed by participants in visit 2 (baseline) and visit 8 (last visit). Form-90 collected in the baseline visit recorded participants' alcohol consumption from 90 days prior to their baseline visit until the day before their baseline visit. Form-90 collected in the last visit recorded participants' alcohol consumption from baseline until the day before their last visit. This outcome measures changes in PDD between visit 8 and visit 2. Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days. The outliers were due to scheduling difficulties.
Outcome measures
| Measure |
Praz/Nal
n=7 Participants
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 Participants
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 Participants
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=8 Participants
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Change in Percent Drinking Days (PDD) (Visit 8 PDD - Visit 2 PDD)
|
-37 percentage of drinking days
Standard Error 10
|
-9 percentage of drinking days
Standard Error 10
|
-14 percentage of drinking days
Standard Error 10
|
-15 percentage of drinking days
Standard Error 9
|
PRIMARY outcome
Timeframe: Visit 2 (baseline) and Visit 8 (last visit). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days due to scheduling difficulties.Population: Only participants who completed the study or had an intention to treat (ITT) were included in analyses.
PHDD was calculated based on self-reported drinking history collected via Form-90. Heavy drinking days were defined as days when participants consumed 4 or more drinks for females and 5 or more drinks for males. Form-90 was completed by participants in the baseline and last visit. Form-90 collected in the baseline visit recorded participants' alcohol consumption 90 days prior to their baseline visit. Form-90 collected in the last visit recorded participants' alcohol consumption from baseline until the day before their last visit. This outcome measures changes in PHDD between visit 8 and visit 2. Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days. The outliers were due to scheduling difficulties.
Outcome measures
| Measure |
Praz/Nal
n=7 Participants
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 Participants
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 Participants
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=8 Participants
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Change in Percent Heavy Drinking Days (PHDD) (Visit 8 PHDD - Visit 2 PHDD)
|
-38 percentage of heavy drinking days
Standard Error 17
|
-8 percentage of heavy drinking days
Standard Error 17
|
-7 percentage of heavy drinking days
Standard Error 17
|
-13 percentage of heavy drinking days
Standard Error 16
|
PRIMARY outcome
Timeframe: Visit 2 (baseline) and visit 8 (last visit). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days due to scheduling difficulties.Population: Only participants who completed the study or had an intention to treat (ITT) were included in analyses.
Alcohol craving was assessed in visit 2 (baseline) and the last visit (visit 8) using the Pennsylvania Alcohol Craving Scale (PACS). The PACS had 5 questions, where each question had six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher scores mean higher craving. This outcome measures the change in PACS scores between visits 2 and 8 (visit 8 PACS score - visit 2 PACS score). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days. The outliers were due to scheduling difficulties.
Outcome measures
| Measure |
Praz/Nal
n=7 Participants
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 Participants
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 Participants
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=8 Participants
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Change in Alcohol Craving (Visit 8 PACS - Visit 2 PACS)
|
-10.5 score on a scale
Standard Error 2.4
|
-4.6 score on a scale
Standard Error 2.4
|
-4.3 score on a scale
Standard Error 2.4
|
-3.5 score on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Visit 2 (baseline) and visit 8 (last visit). Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days due to scheduling difficulties.Population: Only participants who completed the study or had an intention to treat (ITT) were included in analyses.
Average drinks per day of drinking was calculated based on self-reported drinking history collected via Form-90. Drinking days were defined as days when participants consumed alcohol. Form-90 was completed by participants in visit 2 (baseline) and visit 8 (last visit). Form-90 collected in the baseline visit recorded participants' alcohol consumption 90 days prior to their baseline visit. Form-90 collected in the last visit recorded participants' alcohol consumption from baseline until the day before their last visit. This outcome reports the change in the mean drinks between visit 8 and visit 2. Per the protocol, visit 8 is scheduled to occur 42 days (± 7days) after visit 2. In reality, visit 8 occurred 35 to 76 days after visit 2 with the average of 45 days. The outliers were due to scheduling difficulties.
Outcome measures
| Measure |
Praz/Nal
n=7 Participants
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 Participants
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 Participants
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=8 Participants
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
Change in Mean Drinks Per Day of Drinking (Visit 8 - Visit 2)
|
-5.1 drinks
Standard Error 1.7
|
-2.2 drinks
Standard Error 1.7
|
-5.0 drinks
Standard Error 1.7
|
-3.7 drinks
Standard Error 1.6
|
Adverse Events
Praz/Nal
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Praz/Pl
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nal/Pl
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pl/Pl
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 |
Praz/Nal
n=8 participants at risk
Prazosin and Naltrexone.
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
|
Praz/Pl
n=7 participants at risk
Prazosin and Placebo (Naltrexone)
Prazosin will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin: Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
Nal/Pl
n=7 participants at risk
Naltrexone and Placebo (Prazosin)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone: Naltrexone Dosing Days 1-42: 50mg @ 9PM
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
|
Pl/Pl
n=9 participants at risk
Placebo (Prazosin) and Placebo (Naltrexone)
Prazosin Placebo will be taken following this titration schedule:
Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin): Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
Placebo (Naltrexone): Placebo Dosing Days 1-42: 50mg @ 9PM
|
|---|---|---|---|---|
|
General disorders
Dizziness
|
50.0%
4/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
22.2%
2/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Lightheadedness
|
50.0%
4/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
28.6%
2/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
28.6%
2/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Drowsiness
|
25.0%
2/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Lack of energy
|
12.5%
1/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Weakness
|
12.5%
1/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
Renal and urinary disorders
Change in urination
|
12.5%
1/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
Gastrointestinal disorders
Abdominal symptoms
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
11.1%
1/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Decreased appetite
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
22.2%
2/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Vivid dreams, nightmares
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Metallic taste in mouth
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Flushed
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Extreme energy, mania
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
|
General disorders
Insomnia, sleep disturbance
|
0.00%
0/8 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
14.3%
1/7 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
0.00%
0/9 • Participants went through 8 in-person visits (screening, baseline, and visits 3 to 8). Adverse events were collected after the baseline visit, the visit where participants were randomized and received medications, through 3 safety calls and 6 visits (visits 3 to 8). There was one safety call after the baseline visit, visit 3, and visit 4. Depending on whether a participant completed the study or not, adverse events were collected from 1 to 11 weeks.
|
Additional Information
Tracy Simpson, PhD
Veterans Affairs Puget Sound Health Care System
Phone: 206-277-3337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place