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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

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 • NCT01238575
87%
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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025