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Guanfacine for Alcohol Use Disorder (AUD)

RecruitingPhase 2

Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* be assigned as a biological male or female at birth and identify as such
* meet current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) criteria for moderate to severe AUD
* be ≥18 years old and have a body mass index (BMI) of 18-35
* express a desire to quit alcohol as determined by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
* demonstrate a positive urine for alcohol on admission to study procedures
* be able to provide informed verbal and written consent
* be able to read English and complete study evaluations
* be in good health as verified by the intake 1 physical examination

Exclusion Criteria:

* meet criteria for moderate to severe Substance Use Disorder (SUD), excluding alcohol and nicotine
* have a positive screen for substances of abuse, excluding alcohol, nicotine,
* being psychotic or otherwise severely psychiatrically disabled (including suicidal, homicidal, current mania)
* meet criteria for physiological dependence on alcohol requiring medical detoxification
* regular use of medications in the last 6 months that, in the opinion of the site physician may be contraindicated with GXR and be potentially harmful to the participant
* be pregnant or breast feeding
* be using monophasic contraceptives
* have cardiovascular disease including high blood pressure,
* be hypotensive with sitting blood pressure below 100/50 mmHG
* have bradycardia with a sitting heart rate (HR) of \<60 bpm
* show EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>470 msec for women and QTc\>450 msec for men.

About the study

The investigators assess whether guanfacine extended release (GXR; 3mg/d) compared with placebo (PBO) will attenuate drinking and drinking-related factors in N=200 men and women with Alcohol Use Disorder (AUD) across 12-weeks.

What is being tested

Sponsor: Indiana University · Participants: 200 · Started: Oct 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06629259

Locations in the U.S.

IndianaThe Stark Neuroscience Building (Goodman Hall), Indianapolis
New JerseyRutgers School of Health Professionals, Newark

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.