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Alpha-2 Adrenergic Agonist
Guanfacine XR 3mgs/daily for Alcohol Abstinence
Phase 1 & 2
Recruiting
Led By Helen C Fox, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM- V) criteria for moderate to severe Alcohol Use Disorder (AUD)
Must produce positive urine toxicology screens on admission to study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.
Eligible Conditions
- Alcohol Abstinence
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol Consumption
Secondary outcome measures
Alcohol Craving
Attrition rate (%)
Mood
Side effects data
From 2014 Phase 4 trial • 62 Patients • NCT0123857587%
Drowsiness
63%
Fatigue
43%
Decreased Appetite
40%
Emotional/tearful
40%
Dry Mouth
37%
Irritability
30%
Anxiety
30%
Increased Energy
30%
Mid sleep awakening
30%
Headache
27%
Stomachache
23%
Constipation
17%
Aggression
17%
Increased Repetitive Behavior
13%
Depressed Mood
13%
Cough/Congestion
10%
Diarrhea
10%
Silly
10%
Weakness
10%
Vomiting
10%
Self-injury
10%
Nausea
10%
Trouble Falling Asleep
10%
Dizziness
7%
Blurred Vision
7%
Skin rash/Eczema
7%
Nightmares
7%
Enuresis
7%
Increased Appetite
7%
Excessive Talking
3%
Aggressive
3%
Fever
3%
Motor Tics
3%
Skin Picking
100%
80%
60%
40%
20%
0%
Study treatment Arm
Extended-release Guanfacine
Inactive Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Guanfacine XR 3mgs/dailyExperimental Treatment1 Intervention
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)
Group II: Placebo (for guanfacine)Placebo Group1 Intervention
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)
Find a Location
Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,467 Total Patients Enrolled
Helen C Fox, PhDPrincipal InvestigatorStony Brook University
1 Previous Clinical Trials
70 Total Patients Enrolled
Frequently Asked Questions
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