Guanfacine for Alcohol Use Disorder (AUD)

May 7, 2026 updated by: Helen Fox, Indiana University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Helen C Fox, PhD
  • Phone Number: 2036719643
  • Email: helfox@iu.edu

Study Contact Backup

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:
        • Contact:
          • Suchismita Ray, PhD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in % number of days drinking
Time Frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
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
Time Frame: three times per day through week 12.
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of drinks consumed per occasion
Time Frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
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
Time Frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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
Time Frame: five times daily during weeks 1, 2, 5, 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helen C Fox, PhD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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