Trial Outcomes & Findings for Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (NCT NCT02192398)
NCT ID: NCT02192398
Last Updated: 2026-07-06
Results Overview
Changes in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Guanfacine (2mg)
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Guanfacine (1mg)
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Placebo
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
Baseline characteristics by cohort
| Measure |
Guanfacine (2mg)
n=4 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Guanfacine (1mg)
n=3 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Placebo
n=1 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Continuous
|
41 years
n=9 Participants
|
38 years
n=27 Participants
|
22 years
n=267 Participants
|
34 years
n=265 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksChanges in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups.
Outcome measures
| Measure |
Guanfacine (2mg)
n=3 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Guanfacine (1mg)
n=2 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
Placebo
n=1 Participants
Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
1. guanfacine (2mg)
2. guanfacine (1mg)
3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
|
|---|---|---|---|
|
Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain)
|
4.5 score on a scale
Standard Deviation 2.3
|
4.3 score on a scale
Standard Deviation 2.5
|
5 score on a scale
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Guanfacine (2mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Guanfacine (1mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place