Trial Outcomes & Findings for Does Guanfacine Attenuate Stress-Induced Drinking? (NCT NCT02164422)
NCT ID: NCT02164422
Last Updated: 2021-07-08
Results Overview
mL per 15 minutes during 2-hour ad-lib drinking period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
2 hour self administration period during lab sessions held on days 22 and 25
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Guanfacine 3mg/Day
Guanfacine 3mg/day
Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Guanfacine 1.5mg/Day
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Placebo
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
23
|
|
Overall Study
COMPLETED
|
24
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Guanfacine Attenuate Stress-Induced Drinking?
Baseline characteristics by cohort
| Measure |
Guanfacine 3mg/Day
n=24 Participants
Guanfacine 3mg/day
Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Guanfacine 1.5mg/Day
n=20 Participants
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Placebo
n=23 Participants
Placebo
Placebo
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.21 years
STANDARD_DEVIATION 12.504 • n=99 Participants
|
28.65 years
STANDARD_DEVIATION 10.594 • n=107 Participants
|
37.04 years
STANDARD_DEVIATION 13.482 • n=206 Participants
|
34.60 years
STANDARD_DEVIATION 12.754 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
20 participants
n=107 Participants
|
23 participants
n=206 Participants
|
67 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 hour self administration period during lab sessions held on days 22 and 25mL per 15 minutes during 2-hour ad-lib drinking period
Outcome measures
| Measure |
Guanfacine 3mg/Day
n=24 Participants
Guanfacine 3mg/day
Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Guanfacine 1.5mg/Day
n=20 Participants
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Placebo
n=23 Participants
Placebo
Placebo
|
|---|---|---|---|
|
mL Per 15 Minutes
|
85.850 mls of alcohol consumed per 15 minutes
Standard Error 5.217
|
80.575 mls of alcohol consumed per 15 minutes
Standard Error 5.567
|
114.104 mls of alcohol consumed per 15 minutes
Standard Error 5.268
|
Adverse Events
Guanfacine 3mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Guanfacine 1.5mg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
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 |
Guanfacine 3mg/Day
n=25 participants at risk
Guanfacine 3mg/day
Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Guanfacine 1.5mg/Day
n=22 participants at risk
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
|
Placebo
n=23 participants at risk
Placebo
Placebo
|
|---|---|---|---|
|
General disorders
somnolence
|
0.00%
0/25 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/22 • Day 1 to Day 22
Treatment emergent adverse events
|
4.3%
1/23 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
|
General disorders
fatigue
|
4.0%
1/25 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/22 • Day 1 to Day 22
Treatment emergent adverse events
|
8.7%
2/23 • Number of events 2 • Day 1 to Day 22
Treatment emergent adverse events
|
|
General disorders
dizziness
|
4.0%
1/25 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/22 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/23 • Day 1 to Day 22
Treatment emergent adverse events
|
|
Gastrointestinal disorders
dry mouth
|
4.0%
1/25 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
4.5%
1/22 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/23 • Day 1 to Day 22
Treatment emergent adverse events
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/25 • Day 1 to Day 22
Treatment emergent adverse events
|
4.5%
1/22 • Number of events 1 • Day 1 to Day 22
Treatment emergent adverse events
|
0.00%
0/23 • Day 1 to Day 22
Treatment emergent adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place