Actively Recruiting

Phase 2
Age: 21Years - 70Years
All Genders
Healthy Volunteers
NCT03764098

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

316 weeks

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

For this protocol, the investigators plan to collect pilot data to examine sex differences in guanfacine's effect on 1) counteracting stress and stimulation based drinking behavior in the laboratory and 2) improving clinical outcomes during a subsequent treatment phase.

CONDITIONS

Official Title

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders

Who Can Participate

Age: 21Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 or drinks above specified weekly and daily limits for males and females during a consecutive 30-day period prior to baseline
  • Laboratory sessions scheduled to avoid major responsibilities the day after alcohol self-administration
  • Able to take oral medications and willing to follow medication regimen
  • Willing to reduce drinking during treatment period
Not Eligible

You will not qualify if you...

  • Significant current medical conditions including neurological, cardiovascular (blood pressure outside 90/60 to 160/100 mmHg), endocrine, thyroid, renal, liver, 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 past 30 days
  • Women who are pregnant, nursing, or not using approved birth control methods unless surgically sterile or postmenopausal
  • Suicidal, homicidal, or current major mental illness such as schizophrenia, bipolar disorder, major depression, or anxiety disorders
  • Meets DSM V criteria for current ADHD
  • Only one member per household allowed
  • Baseline EKG showing conduction abnormalities or arrhythmias
  • Known intolerance to guanfacine or alpha blockers
  • History of fainting, heart failure, myocardial infarction, or impaired liver or kidney function
  • Treatment with antihypertensive drugs or alpha blockers
  • Use of CNS depressants
  • Likely to have significant alcohol withdrawal symptoms
  • Use of investigational drug within 4 weeks prior to treatment
  • Participation in other studies with excessive blood sampling or interventions within past 8 weeks
  • Desire to completely abstain from alcohol at intake
  • Currently in treatment for alcohol use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

M

Meaghan Lavery

CONTACT

S

Sabrina Coppola

CONTACT

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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