Guanfacine for Alcohol Use Disorder (AUD)

This study is testing whether guanfacine extended release (GXR), a 3mg tablet taken once daily, can help reduce drinking in people with Alcohol Use Disorder (AUD). Researchers will compare guanfacine to a placebo (an inactive pill) over 12 weeks. They will look at how much participants drink, their blood alcohol levels, and how much they drink after stressful events. You may be able to join if you are 18 or older, identify as the gender you were assigned at birth, have moderate to severe AUD, and want to quit drinking. The study aims to enroll 200 men and women, but its current status is unclear.

Study design
This is an interventional study comparing guanfacine extended release to a placebo in 200 men and women with Alcohol Use Disorder (AUD). Participants will be randomly assigned to receive either the active drug or the placebo.
What's involved
You would take a tablet once daily, with the dose gradually increasing over three weeks and then tapering off over two weeks. You would also provide brief reports throughout the day and evening, have blood alcohol concentration (BAC) levels collected three times daily for 12 weeks, and participate in twice-weekly remote visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as changes in drinking days and blood alcohol levels, are measured through week 12 of the study.

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NCT06629259

Guanfacine for Alcohol Use Disorder (AUD)

Recruiting
PHASE2Ages 18+InterventionalPrevention
Indiana University
~200 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Guanfacine Extended Release (XR)Placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in % number of days drinking
Measured over five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
+3 more outcomes measured
Alcohol Use Disorder
2 sites across 2 states
Indiana1
New Jersey1
  • Helen C Fox, PhD · PRINCIPAL_INVESTIGATOR · Associate Professor

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Eligibility criteria

Inclusion

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

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.
  • Change in % number of days drinkingfive times daily during weeks 1, 2, 5, 6 and twice weekly through week 12

    Self-reports of alcohol use

  • Change in Blood Alcohol Concentration (BAC) levelsthree times per day through week 12.

    BAC levels will be collected using a remote breathalyzer application called BACtrack

  • Change in no. of drinks consumed following stressfive times daily during weeks 1, 2, 5, 6

    Self reports of alcohol use will be collected following stress, which will be measured using a visual analog scale (VAS) anchored from 0 (not stressed at all) to 100 (extremely stressed).

  • Change in alcohol craving following stressfive times daily during weeks 1, 2, 5, 6

    Self-reports of alcohol craving will be collected using a VAS anchored from 0 (Not craving at all) to 100 (Craving extremely) following self-reported stress. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed).