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Alcohol Use DisorderPhase 2NCT06629259

Guanfacine for Alcohol Use Disorder (AUD)

A Phase 2 study testing Guanfacine Extended Release (XR) in people with Alcohol Use Disorder, run by Indiana University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Guanfacine Extended Release (XR)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
2 sitesUnited States
Study dates
3 Oct 2025to 7 Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Helen C Fox, PhD contact

2036719643

helfox@iu.edu

Mitch Smith contact

3172785475

smithmib@iu.edu

United States2 sites, 2 recruiting

  • The Stark Neuroscience Building (Goodman Hall)

    Indianapolis, Indiana, 46202

    Helen C Fox, PhD, 203-671-9643, helfox@iu.edu

    Recruiting

  • Rutgers School of Health Professionals

    Newark, New Jersey, 07107

    Suchismita Ray, PhD, smita@rutgers.edu

    Suchismita Ray, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Guanfacine Extended Release (XR), Placebo
Keywords
Alcohol Use Disorder, Stress, Guanfacine, Sex Differences
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guanfacine Extended Release (XR)Drug

    Also called Intuniv

    3mg tablet once daily

  • PlaceboDrug

    placebo tablet once daily

Study groups in NCT06629259
Study groupRoleWhat they receive
Guanfacine Extended Release (XR)ExperimentalParticipants receive guanfacine XR, 3mg tablet orally, once per day for 12 weeks
Receives: Drug: Guanfacine Extended Release (XR)
PlaceboPlacebo comparatorParticipants receive guanfacine XR, placebo tablet orally, once per day for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in % number of days drinking

    Self-reports of alcohol use

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

  2. Change in Blood Alcohol Concentration (BAC) levels

    BAC levels will be collected using a remote breathalyzer application called BACtrack

    Measured: three times per day through week 12.

  3. 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).

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

  4. 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).

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

Secondary outcomes (6)

  1. Change in number of drinks consumed per occasion

    Self-reports of alcohol use

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

  2. Change in number of binge episodes

    Self-reports of alcohol use

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

  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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start3 Oct 2025
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion7 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized double blind, placebo controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629259
Sponsor's protocol ID
24432
Other IDs
R01AA031662-01
Status last verified
May 2026
First submitted
23 Sep 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guanfacine Extended Release (XR) in people with Alcohol Use Disorder, run by Indiana University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Helen C Fox, PhD (2036719643, helfox@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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