Actively Recruiting
Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
Led by Yale University · Updated on 2026-02-27
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the drug guanfacine affects drinking behavior in adults with alcohol use disorders, focusing on differences between women and men. This phase 2 trial aims to see if guanfacine can reduce stress- and stimulation-driven drinking in a controlled laboratory setting and improve clinical outcomes during treatment. The study is double-blind and placebo-controlled, enrolling adults diagnosed with alcohol use disorder. Participants are randomly assigned to receive either guanfacine extended release (6 mg/day) or a placebo. The treatment starts with a 3-week dose escalation phase to reach steady medication levels, followed by three lab sessions where personalized imagery is used to trigger stress, stimulation, or relaxation before a 2-hour alcohol self-administration period. After these sessions, participants enter a 6-week treatment phase combining medication with weekly medical management appointments. Medication is tapered over 5 days at the study’s end, with follow-up assessments 1 and 3 months after treatment. During the study, participants undergo eligibility screening including an intake session and physical exam. Researchers monitor alcohol consumption during lab sessions and track reductions in heavy drinking days during treatment. Safety is assessed through adverse event evaluations at each visit. The trial includes blood pressure monitoring and urine drug screening, with participant activities involving medication adherence and regular clinical visits over several months to assess treatment effects and safety.
CONDITIONS
Brief Title
Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 70 years
- Able to read and write English
- Meets DSM V criteria for current (past 6 months) alcohol use disorder
- For males: drinks more than 14 drinks per week and exceeds 4 drinks per day at least twice per week
- For females: drinks more than 7 drinks per week and exceeds 3 drinks per day at least twice per week
- Drinking criteria met during a consecutive 30-day period prior to baseline
- Able to take oral medications and willing to follow the medication regimen
- Willing to reduce drinking during the treatment period
- Laboratory sessions scheduled to avoid major responsibilities the following day that might limit drinking during self-administration sessions
You will not qualify if you...
- Significant current medical conditions including neurological, cardiovascular (blood pressure above 160/100 or below 90/60 mmHg), endocrine, thyroid, renal, liver diseases, seizures, delirium, hallucinations, or unstable conditions including HIV
- Current DSM V substance use disorder other than alcohol abuse or nicotine dependence
- Positive urine drug screen for illicit drugs at intake
- Use of psychoactive drugs including anxiolytics and antidepressants in the past 30 days
- Women who are pregnant, nursing, or not using approved birth control unless surgically sterile or postmenopausal
- Suicidal, homicidal, or current mental illness such as schizophrenia, bipolar disorder, major depression, or anxiety disorders
- Current ADHD diagnosis
- Only one member per household may participate
- Clinically significant heart conduction abnormalities or arrhythmias
- Known intolerance to guanfacine or alpha blockers
- History of fainting, heart failure, myocardial infarction, or impaired liver/renal function
- Treatment with antihypertensive drugs or alpha adrenergic blockers
- Use of CNS depressants like phenothiazines, barbiturates, benzodiazepines
- Likely to have severe alcohol withdrawal symptoms
- Use of investigational drugs in the past 4 weeks
- Participation in other studies with excessive blood sampling or interventional measures in the past 8 weeks
- Desire to completely abstain from alcohol at intake
- Currently in treatment for alcohol use disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants begin titration to steady state medication levels with guanfacine or placebo over a 3 week period.
Weekly visits for medication titration
Duration - 1 week
Participants complete three laboratory sessions involving personalized imagery followed by a 2 hour alcohol self-administration period to evaluate drinking behavior.
3 laboratory visits during one week
Duration - 6 weeks
Participants receive guanfacine or placebo combined with a medical management platform delivered at weekly appointments.
Weekly visits for treatment and medical management
Duration - 5 days
Participants taper off medication over a 5 day period following the treatment phase.
1 visit for medication taper monitoring
Duration - 3 months
Participants complete follow-up evaluations at 1 and 3 months after the end of treatment to assess outcomes.
2 follow-up visits (at 1 and 3 months post-treatment)
Trial Site Locations
Total: 1 location
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
M
Meaghan Lavery
S
Sabrina Coppola
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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