Guanfacine for Alcohol Use Disorder (AUD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Guanfacine Extended Release (XR); Drug: Placebo

Detailed Description

This is a study to examine the efficacy of guanfacine extended release (GXR) (3mg/d) compared with placebo (PBO) in reducing drinking in N=200 men and women with Alcohol Use Disorder (AUD). The study will be conducted across two sites for 12-weeks. Indiana University will be the primary site and Rutgers University, the secondary site. Participants at both sites will be randomized to either GXR (3mg/d) or placebo (PBO), and titrated to full dose over a three week period. After remaining at full dose for 7 weeks a two week schedule will be used to taper participants off the medication. During the study the investigators will collect brief reports throughout the day and evening of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation at weeks 1 and 2 (baseline) and weeks 5 and 6 (steady state). Additionally, blood alcohol concentration (BAC) levels will be collected three times per day for the full 12-weeks. Daily encrypted video recordings will be used to monitor medication compliance, and participants will also take part in twice weekly remote visits to assess safety, vitals, collect urines, monitor alcohol use, and receive weekly Medical Management. It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Helen C Fox, PhD; Phone Number: 2036719643; Email: helfox@iu.edu
• Study Contact Backup: Name: Mitch Smith; Phone Number: 3172785475; Email: smithmib@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • The Stark Neuroscience Building (Goodman Hall)
      • Contact: Helen C Fox, PhD; Phone Number: 203-671-9643; Email: helfox@iu.edu
  • New Jersey
    • Newark, New Jersey, United States, 07107
      • Recruiting
      • Rutgers School of Health Professionals
      • Contact: Suchismita Ray, PhD; Email: smita@rutgers.edu
      • Contact: Suchismita Ray, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guanfacine Extended Release (XR); Participants receive guanfacine XR, 3mg tablet orally, once per day for 12 weeks	Drug: Guanfacine Extended Release (XR); 3mg tablet once daily; Other Names: Intuniv
Placebo Comparator: Placebo; Participants receive guanfacine XR, placebo tablet orally, once per day for 12 weeks	Drug: Placebo; placebo tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in % number of days drinking	Self-reports of alcohol use	five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in Blood Alcohol Concentration (BAC) levels	BAC levels will be collected using a remote breathalyzer application called BACtrack	three times per day through week 12.
Change in no. of drinks consumed following stress	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).	five times daily during weeks 1, 2, 5, 6
Change in alcohol craving following stress	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).	five times daily during weeks 1, 2, 5, 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of drinks consumed per occasion	Self-reports of alcohol use	five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in number of binge episodes	Self-reports of alcohol use	five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in negative mood following stress	Self-reports of negative mood will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater negative mood. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed).	five times daily during weeks 1, 2, 5, 6
Change in anxiety following stress	Self-reports of anxiety will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater anxiety. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed).	five times daily during weeks 1, 2, 5, 6
Change in arousal following stress	Self-reports of arousal will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater arousal. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed).	five times daily during weeks 1, 2, 5, 6
Change in emotion regulation following stress	Self-reports of emotion regulation will be collected using The Difficulties in Emotion Regulation Scale (DERS) developed for ecological momentary assessment (EMA) following self-reported stress (visual analog scale; VAS). The DERS is scored from 36-180 across all items, with a higher score representing greater difficulties in regulating emotion. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed).	five times daily during weeks 1, 2, 5, 6

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Helen C Fox, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 7, 2029

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Alcohol Use Disorder; Guanfacine; Sex Differences
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Organic Chemicals; Carboxylic Acids; Guanidines; Amidines; Acids, Carbocyclic; Phenylacetates; Guanfacine
• Other Study ID Numbers: 24432; R01AA031662-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes