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Recruiting Phase 2 NCT06629259

Guanfacine for Alcohol Use Disorder (AUD)

Trial Parameters

Condition Alcohol Use Disorder
Sponsor Indiana University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-01
Completion 2029-08-31
Interventions
Guanfacine Extended Release (XR)Placebo

Brief 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.

Eligibility Criteria

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 ph

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