RecruitingPhase 2NCT06629259
Guanfacine for Alcohol Use Disorder (AUD)
Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach
Sponsor
Indiana University
Enrollment
200 participants
Start Date
Sep 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria11
- 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.
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Interventions
DRUGGuanfacine Extended Release (XR)
3mg tablet once daily
DRUGPlacebo
placebo tablet once daily
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06629259
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