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New treatment option for Alcohol Use Disorder
Official title Guanfacine for Alcohol Use Disorder (AUD)
ClinicalTrials.gov ID: NCT06629259
What this study is testing
What is Guanfacine Extended Release (XR)?
Guanfacine Extended Release (XR) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Also referred to as Intuniv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- be pregnant or breast feeding
See the full eligibility 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.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Newark, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.