NCT06629259 · Indiana University
Guanfacine for Alcohol Use Disorder (AUD)
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Guanfacine Extended Release (XR)
3mg tablet once daily
DRUG
Placebo
placebo tablet once daily
Primary outcome measures
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
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
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).
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Indianapolis, Indiana
- Newark, New Jersey
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations