Recruiting
Phase 2

Guanfacine Extended Release

Sponsor:

Indiana University

Code:

NCT06629259

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Guanfacine Extended Release (XR)

Placebo

Study Details

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

Study ID

NCT06629259

Start date

Oct 3, 2025

Status verified date

May, 2026

Completion date

Sep 7, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Guanfacine Extended Release (XR)

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

placebo comparator: Placebo

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

Interventions

Guanfacine Extended Release (XR)

3mg tablet once daily

Placebo

placebo tablet once daily

Primary outcome measure

  • Change in % number of days drinking [ Time Frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12 ]
  • Change in Blood Alcohol Concentration (BAC) levels [ Time Frame: three times per day through week 12. ]
  • Change in no. of drinks consumed following stress [ Time Frame: five times daily during weeks 1, 2, 5, 6 ]
  • Change in alcohol craving following stress [ Time Frame: five times daily during weeks 1, 2, 5, 6 ]

Central Contacts and Locations

Central contacts

Helen C Fox, PhD

2036719643helfox@iu.edu

Mitch Smith

3172785475smithmib@iu.edu

Locations

The Stark Neuroscience Building (Goodman Hall)

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Helen C Fox, PhD

203-671-9643helfox@iu.edu

Rutgers School of Health Professionals

Recruiting

Newark, New Jersey, United States, 07107

Contacts

Suchismita Ray, PhD

smita@rutgers.edu

More Information

Sponsor

Indiana University

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Alcohol Use Disorder
  • Stress
  • Guanfacine
  • Sex Differences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-11.