Guanfacine extended-release to reduce drinking in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial will enroll 200 adults with moderate to severe alcohol use disorder across two sites (Indiana University and Rutgers) and follow them for 12 weeks. Participants will be randomized to guanfacine XR (titrated to 3 mg/day over three weeks, maintained for seven weeks, then tapered for two weeks) or matching placebo. The study uses frequent remote monitoring including three daily BAC measures, brief ecological reports of drinking, stress, craving and mood at baseline and steady state, daily encrypted medication videos, and twice-weekly remote safety and medication-management visits. Investigators plan to examine overall drinking outcomes and whether women show greater benefit than men.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Stark Neuroscience Building (Goodman Hall)
  Indianapolis, Indiana, United States Recruiting
• Rutgers School of Health Professionals
  Newark, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Helen C Fox, PhD — Associate Professor
• Study coordinator: Helen C Fox, PhD
• Email: helfox@iu.edu
• Phone: 2036719643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.