Phase
Condition
Addictions
Alcohol Use Disorder
Alcohol Dependence
Treatment
Placebo
Guanfacine Extended Release (XR)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andTreatment 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
Exclusion Criteria:
meet criteria for moderate to severe Substance Use Disorder (SUD), excluding alcoholand 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 medicaldetoxification
regular use of medications in the last 6 months that, in the opinion of the sitephysician may be contraindicated with GXR and be potentially harmful to theparticipant
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, includinga Bazett's corrected QT interval (QTc) >470 msec for women and QTc>450 msec for men.
Study Design
Study Description
Connect with a study center
The Stark Neuroscience Building (Goodman Hall)
Indianapolis, Indiana 46202
United StatesSite Not Available
The Stark Neuroscience Building (Goodman Hall)
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Rutgers School of Health Professionals
Newark, New Jersey 07107
United StatesSite Not Available
Rutgers School of Health Professionals
Newark 5101798, New Jersey 5101760 07107
United StatesActive - Recruiting
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