RECRUITING

Guanfacine for Alcohol Use Disorder (AUD)

Conditions

Alcohol Use Disorder Stress Guanfacine Sex Differences

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-01

Study Completion:2029-09-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06629259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Helen C Fox, PhD

CONTACT

2036719643

helfox@iu.edu

Mitch Smith

CONTACT

3172785475

smithmib@iu.edu

Principal Investigator

Helen C Fox, PhD

PRINCIPAL_INVESTIGATOR

Associate Professor

Study Locations (Sites)

The Stark Neuroscience Building (Goodman Hall)

Indianapolis, Indiana, 46202

United States

Rutgers School of Health Professionals

Newark, New Jersey, 07107

United States

Collaborators and Investigators

Sponsor: Indiana University

Helen C Fox, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01

Study Completion Date2029-09-07

Study Record Updates

Study Start Date2025-09-01

Study Completion Date2029-09-07

Terms related to this study

Keywords Provided by Researchers

Alcohol Use Disorder
Stress
Guanfacine
Sex Differences

Additional Relevant MeSH Terms

Alcohol Use Disorder