Trial Outcomes & Findings for Guanfacine to Improve Substance Use Outcomes in Women (NCT NCT03980184)
NCT ID: NCT03980184
Last Updated: 2024-03-20
Results Overview
Days of any drug use during the 10 week period (assessed daily and weekly via self report). Data presented here is the average between week 10 and week 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
10 weeks
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Study Medication
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
Began Treatment
|
36
|
34
|
|
Overall Study
COMPLETED
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
Study Medication
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Overall Study
Dropped out before treatment
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
Baseline Characteristics
Guanfacine to Improve Substance Use Outcomes in Women
Baseline characteristics by cohort
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
40 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Education
|
13.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 2 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Married/Cohabitating
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Number of participants that used cocaine in the past 30 days
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Mean days cocaine use in the past 30 days
|
14 days
STANDARD_DEVIATION 12.1 • n=5 Participants
|
11.0 days
STANDARD_DEVIATION 8.7 • n=7 Participants
|
12.7 days
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Number of participants that used opioids in the past 30 days
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Mean days opioid use in the past 30 days
|
12.1 days
STANDARD_DEVIATION 12.7 • n=5 Participants
|
20.6 days
STANDARD_DEVIATION 11.5 • n=7 Participants
|
16.4 days
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Number of participants that used cannabis in the past 30 days
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Mean days cannabis use in the past 30 days
|
19.7 days
STANDARD_DEVIATION 11.3 • n=5 Participants
|
20 days
STANDARD_DEVIATION 12.7 • n=7 Participants
|
19.8 days
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Number of participants that used alcohol in the past 30 days
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Mean days alcohol use in the past 30 days
|
15 days
STANDARD_DEVIATION 10.1 • n=5 Participants
|
13.8 days
STANDARD_DEVIATION 8.9 • n=7 Participants
|
14.4 days
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Number of participants that used tobacco in the past 30 days
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Mean days tobacco use in the past 30 days
|
28.1 days
STANDARD_DEVIATION 6 • n=5 Participants
|
29.2 days
STANDARD_DEVIATION 4.5 • n=7 Participants
|
28.7 days
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Addiction Severity Index Score (ASI)
|
6.6 score on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
6.4 score on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
6.5 score on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Days of any drug use during the 10 week period (assessed daily and weekly via self report). Data presented here is the average between week 10 and week 1.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Drug Use With Substance Use Calendar
|
-6.35 days
Standard Deviation 1
|
-5.61 days
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Substance use calendar self report of daily drug use during 10 week treatment periods. Data presented here is the average between week 10 and week 1.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Abstinence Days
|
0.28 days
Standard Deviation 0.25
|
-0.12 days
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.The possible range for the average craving measure is 0 - 100. A higher score on the measure = greater avg drug craving.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Average Drug Craving
|
-14.6 score on a scale
Standard Deviation 4.4
|
-21.9 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. Data presented here is the number of participants that had any adverse events while on study.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event
|
21 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Repeated assessment of 14-item Perceived Stress Scale (score range: 0-53, higher scores are worse) assessed weekly. Scores are the average change between week 10 and week 1.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Stress Scores
|
-2.8 score on a scale
Standard Deviation 2.9
|
7.8 score on a scale
Standard Deviation 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Repeated assessment of 14-item Hamilton Anxiety Scale (score range: 0-56, higher score is worse outcome) assessed weekly over 10 weeks. Scores are the average change between week 10 and week 1.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Anxiety Levels
|
-1.9 score on a scale
Standard Deviation 2.2
|
-0.8 score on a scale
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksPopulation: Participants who were randomized and received treatment.
Repeated assessment of 17-item Hamilton Depression Scale (score range: 0-53, higher score is worse outcome) assessed weekly over 10 weeks. Scores are the average change between week 10 and week 1.
Outcome measures
| Measure |
Study Medication
n=36 Participants
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 Participants
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Change in Depression Levels
|
0.5 score on a scale
Standard Deviation 2.3
|
0.6 score on a scale
Standard Deviation 1.4
|
Adverse Events
Study Medication
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Medication
n=36 participants at risk
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 participants at risk
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
Other adverse events
| Measure |
Study Medication
n=36 participants at risk
guanfacine 3mg/day (GUA)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
Placebo
n=34 participants at risk
placebo (PBO)
Guanfacine: Guanfacine 3mg/day Versus Placebo
Behavioral Counseling: placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.8%
1/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Nervous system disorders
Dizziness
|
11.1%
4/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Nervous system disorders
Somnolence
|
2.8%
1/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
8/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
General disorders
Fever
|
0.00%
0/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • 10 weeks
|
5.9%
2/34 • 10 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
2/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.6%
2/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
General disorders
Pain
|
11.1%
4/36 • 10 weeks
|
11.8%
4/34 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.8%
1/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
|
General disorders
Fatigue
|
8.3%
3/36 • 10 weeks
|
8.8%
3/34 • 10 weeks
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.6%
2/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.8%
1/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.6%
2/36 • 10 weeks
|
0.00%
0/34 • 10 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/36 • 10 weeks
|
2.9%
1/34 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place