Trial Outcomes & Findings for Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD) (NCT NCT03137082)
NCT ID: NCT03137082
Last Updated: 2024-06-05
Results Overview
Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.
COMPLETED
PHASE1/PHASE2
32 participants
12 weeks
2024-06-05
Participant Flow
Participants were recruited from flyers posted in and around Stony Brook Hospital and its outpatient facilities, in addition to advertisements on social media. The first participant was enrolled in July 2017 and the last in March 2020
Following consent, participants were scheduled for an eligibility intake (including clinical and physical assessments). If eligible, they were scheduled for a second intake which included completing baseline assessments of alcohol and substance use in addition to alcohol craving, mood, anxiety and emotion regulation. Of the 32 women consented, N=17 did not meet criteria and N=15 were eligible and randomized onto study medication.
Participant milestones
| Measure |
Guanfacine XR 3mgs/Daily
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Guanfacine XR 3mgs/Daily
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Baseline characteristics by cohort
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
% no. of drinking days in last 3 months
|
50.1 percentage of days
STANDARD_DEVIATION 36.0 • n=5 Participants
|
66.5 percentage of days
STANDARD_DEVIATION 39.1 • n=7 Participants
|
58.3 percentage of days
STANDARD_DEVIATION 37.6 • n=5 Participants
|
|
no. of drinks consumed per occasion
|
4.75 drinks per occasion
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.9 drinks per occasion
STANDARD_DEVIATION 4.2 • n=7 Participants
|
4.8 drinks per occasion
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
% no. of binge drinking days in last 3 months
|
41.1 % no. of binge drinking days
STANDARD_DEVIATION 28.7 • n=5 Participants
|
35.4 % no. of binge drinking days
STANDARD_DEVIATION 36.1 • n=7 Participants
|
38.3 % no. of binge drinking days
STANDARD_DEVIATION 32.4 • n=5 Participants
|
|
Depressive Symptomatology
|
17.6 units on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
11.83 units on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
14.7 units on a scale
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
no. of smokers (tobacco)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPercentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Percentage of Days Abstinent
|
74.7 percentage of days abstinent
Standard Deviation 27.4
|
50.6 percentage of days abstinent
Standard Deviation 26.5
|
PRIMARY outcome
Timeframe: 12 weeksPercentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
15.5 percentage heavy drinking days
Standard Deviation 26.7
|
30.6 percentage heavy drinking days
Standard Deviation 26.7
|
PRIMARY outcome
Timeframe: 12 weeksUrine screening will be conducted twice per week across the trial.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Alcohol Consumption (Percentage of Negative Urines)
|
45.3 percentage of negative urines
Standard Deviation 35.7
|
35.2 percentage of negative urines
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 2 times per week for 12 weeksThe Anxiety subscale of the Profile of Mood States (POMS) was administered to assess anxiety. The subscale comprises 9 adjectives that describe anxiety-related feelings, and participants are required to rate the extent to which they are experiencing each feeling at that moment, from 0= not at all; 1= a little; 2= moderately; 3= quite a bit; 4= extremely. Possible scores range from 0 to 36, with higher scores representing higher levels of anxiety. Anxiety ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from baseline anxiety. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean anxiety compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Mood (Anxiety)
|
-8.2 scores on a scale
Standard Deviation 8.2
|
-0.75 scores on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 2 times per week for 12 weeksThe Depression subscale of the Profile of Mood States (POMS) was administered to assess depression. The subscale comprises 15 adjectives that describe depression-related feelings, and participants are required to rate the extent to which they are experiencing each feeling at that moment, from 0= not at all; 1= a little; 2= moderately; 3= quite a bit; 4= extremely. Possible scores range from 0 to 60, with higher scores representing higher levels of depression. Depression ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from baseline depression. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean depression compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Mood (Depression)
|
-13.9 scores on a scale
Standard Deviation 13.3
|
0.03 scores on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 12-weeksThe desire for using alcohol was assessed using a 10-point visual analog scale (VAS) in which 1 = 'not at all' and 10 = 'extremely high'. Alcohol craving ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from baseline alcohol craving. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean alcohol craving compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Alcohol Craving
|
-1.6 scores on a scale
Standard Deviation 1.4
|
-1.9 scores on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 12-weeksWe used the Impulse Control Difficulties subscale (IMPULSE) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in impulse control across the trial. The DERS was administered two times per week, and the IMPULSE subscale comprised 6 items with a potential score range of 6 to 30 with higher scores representing greater difficulties in impulse control. Each time-point represents change from baseline impulse control difficulties. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in impulse control compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Difficulties in Impulse Control)
|
-2.8 scores on a scale
Standard Deviation 2.4
|
0.85 scores on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 12-weekWe used the Difficulties in Engaging in Goal-Directed Behavior (GOALS) subscale of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in goal-directed behavior across the trial. The DERS was administered two times per week (24 time-points) and the GOALS subscale comprised 5 items with a potential score range of 5 to 25 with higher scores representing greater difficulties in engaging in goal-directed behavior. Each time-point represented change from baseline GOALS. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in engaging in goal-directed behavior compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Difficulties With Engaging in Goal Related Behavior)
|
-3.0 scores on a scale
Standard Deviation 3.6
|
0.95 scores on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 12-weeksWe used the Lack of Emotional Clarity subscale (CLARITY) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in emotional clarity across the trial. The DERS was administered two times per week, and the CLARITY subscale comprised 5 items with a potential score range of 5 to 25 with higher scores representing greater difficulties in emotional clarity. Each time-point represents change from baseline difficulties in emotional clarity. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in emotional clarity compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Difficulties With Emotional Clarity)
|
-2.3 units on a scale
Standard Deviation 2.8
|
-0.71 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 12-weeksWe used the Limited Access to Emotion Regulation Strategies subscale (STRATEGIES) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in ability to access emotion regulation strategies across the trial. The DERS was administered two times per week, and the STRATEGIES subscale comprised 8 items with a potential score range of 8 to 40 with higher scores representing greater difficulties in accessing emotion regulation strategies. Each time-point represents change from baseline STRATEGIES. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in accessing emotion regulation strategies compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Limited Access to Emotion Regulation Strategies)
|
-5.1 scores on a scale
Standard Deviation 5.4
|
-0.28 scores on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 12-weeksWe used the Lack of Emotional Awareness subscale (AWARENESS) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in emotional awareness across the trial. The DERS was administered two times per week, and the AWARENESS subscale comprised of 6 items with a potential score range of 6 to 30 with higher scores representing greater a greater lack of emotional awareness. Each time-point represents change from baseline emotional awareness. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in emotional awareness compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Difficulties With Emotional Awareness)
|
-1.6 scores on a scale
Standard Deviation 4.3
|
-2.9 scores on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 12-WeekWe used the Non-Acceptance of Emotional Responses subscale (NON-ACCEPTANCE) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in non-acceptance of emotional responses across the trial. The DERS was administered two times per week, and the NON-ACCEPTANCE subscale comprised 6 items with a potential score range of 6 to 30 with higher scores representing greater difficulties in acceptance of emotional response. Each time-point represents change from baseline NON-ACCEPTANCE. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties regarding non-acceptance of emotional responses compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Non-Acceptance of Emotional Responses)
|
-6.4 scores on a scale
Standard Deviation 5.7
|
-0.88 scores on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 12-weeksWe used the Total score of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in overall emotion regulation across the trial. The DERS was administered two times per week, and comprised 41 items with a potential score range of 41 to 164 with higher scores representing greater difficulties in emotion regulation. Each time-point represents change from baseline emotion regulation difficulties. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties regarding emotion regulation compared with baseline.
Outcome measures
| Measure |
Guanfacine XR 3mgs/Daily
n=8 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 Participants
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Emotion Regulation (Total Score)
|
-19.8 scores on a scale
Standard Deviation 17.3
|
-4.5 scores on a scale
Standard Deviation 21.3
|
Adverse Events
Guanfacine XR 3mgs/Daily
Placebo (for Guanfacine)
Serious adverse events
| Measure |
Guanfacine XR 3mgs/Daily
n=8 participants at risk
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 participants at risk
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
Reproductive system and breast disorders
Pelvic Pain
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
Other adverse events
| Measure |
Guanfacine XR 3mgs/Daily
n=8 participants at risk
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet
|
Placebo (for Guanfacine)
n=7 participants at risk
* Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets
|
|---|---|---|
|
General disorders
Headaches
|
25.0%
2/8 • Number of events 2 • 12-weeks
|
14.3%
1/7 • Number of events 1 • 12-weeks
|
|
General disorders
Dry Mouth
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
14.3%
1/7 • Number of events 1 • 12-weeks
|
|
General disorders
Upset Stomach
|
25.0%
2/8 • Number of events 2 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Shakiness
|
0.00%
0/8 • 12-weeks
|
14.3%
1/7 • Number of events 1 • 12-weeks
|
|
General disorders
Weight Gain
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Appetite Loss
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Nightmares
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Enuresis
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Itchiness
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • 12-weeks
|
0.00%
0/7 • 12-weeks
|
|
General disorders
Urinary Tract Infection
|
0.00%
0/8 • 12-weeks
|
14.3%
1/7 • Number of events 1 • 12-weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place