Guanfacine for Alcohol Use Disorder (AUD) (NCT06629259) | Clinical Trial Compass
RecruitingPhase 2
Guanfacine for Alcohol Use Disorder (AUD)
United States200 participantsStarted 2025-10-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* sh…
What they're measuring
1
Change in % number of days drinking
Timeframe: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
2
Change in Blood Alcohol Concentration (BAC) levels
Timeframe: three times per day through week 12.
3
Change in no. of drinks consumed following stress
Timeframe: five times daily during weeks 1, 2, 5, 6
4
Change in alcohol craving following stress
Timeframe: five times daily during weeks 1, 2, 5, 6