Guanfacine for Alcohol Use Disorder (AUD)

NCT06629259 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 24432R01AA031662-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Stress; Guanfacine; Sex Differences

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in number of drinks consumed per occasion

  five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12

• Change in number of binge episodes

  five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12

• Change in negative mood following stress

  five times daily during weeks 1, 2, 5, 6

• Change in anxiety following stress

  five times daily during weeks 1, 2, 5, 6

• Change in arousal following stress

  five times daily during weeks 1, 2, 5, 6

Study Arms (2)

Guanfacine Extended Release (XR)

EXPERIMENTAL

Participants receive guanfacine XR, 3mg tablet orally, once per day for 12 weeks

Drug: Guanfacine Extended Release (XR)

Placebo

PLACEBO COMPARATOR

Participants receive guanfacine XR, placebo tablet orally, once per day for 12 weeks

Drug: Placebo

Interventions

Guanfacine Extended Release (XR) DRUG

3mg tablet once daily

Also known as: Intuniv

Guanfacine Extended Release (XR)

Placebo DRUG

placebo tablet once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: must be assigned as a biological male or female at birth, and identify as such
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

The Stark Neuroscience Building (Goodman Hall)

Indianapolis, Indiana, 46202, United States

RECRUITING

Rutgers School of Health Professionals

Newark, New Jersey, 07107, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Helen C Fox, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen C Fox, PhD

CONTACT

2036719643; helfox@iu.edu

Mitch Smith

CONTACT

3172785475; smithmib@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized double blind, placebo controlled

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 8, 2024
• Study Start: October 3, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 7, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)