Study of Guanfacines Effects on Drinking Behavior in Men and Women with Alcohol Use Disorders Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are studying how the drug guanfacine affects drinking behavior in adults with alcohol use disorders, focusing on differences between women and men. This phase 2 trial aims to see if guanfacine can reduce stress- and stimulation-driven drinking in a controlled laboratory setting and improve clinical outcomes during treatment. The study is double-blind and placebo-controlled, enrolling adults diagnosed with alcohol use disorder. Participants are randomly assigned to receive either guanfacine extended release 6 mgday or a placebo. The treatment starts with a 3-week dose escalation phase to reach steady medication levels, followed by three lab sessions where personalized imagery is used to trigger stress, stimulation, or relaxation before a 2-hour alcohol self-administration period. After these sessions, participants enter a 6-week treatment phase combining medication with weekly medical management appointments. Medication is tapered over 5 days at the studys end, with follow-up assessments 1 and 3 months after treatment. During the study, participants undergo eligibility screening including an intake session and physical exam. Researchers monitor alcohol consumption during lab sessions and track reductions in heavy drinking days during treatment. Safety is assessed through adverse event evaluations at each visit. The trial includes blood pressure monitoring and urine drug screening, with participant activities involving medication adherence and regular clinical visits over several months to assess treatment effects and safety.

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders