Phase 2 Study of Doxazosin as a New Treatment for Alcohol Use Disorder in Adults

What this Trial Is About

Researchers are evaluating the role of stress in the development of treatments for Alcohol Use Disorder AUD by studying the effects of alpha-1 receptor blockade. This research aims to replicate findings from an earlier pilot trial and focuses on doxazosin as a potential pharmacological treatment. The trial is a Phase 2, randomized, double-blind clinical study involving 184 individuals seeking treatment for AUD. Participants will be randomly assigned to receive either doxazosin at 16 mg or the maximum tolerated dose, or a matching placebo, over a 16-week period. The study uses a quadruple-blind design to compare the effects of the drug to placebo. The dosing is carefully monitored to ensure safety and adherence. During the study, participants will have regular visits to assess alcohol consumption, craving, and other health factors. The primary outcome measure is alcohol consumption at 6 weeks, while secondary measures include alcohol craving assessed both one day and six weeks after treatment begins. Safety and adherence are monitored through medical history, physical exams, lab tests, and breath alcohol checks. The total participation duration is 16 weeks, with thorough follow-up throughout the trial.

Alpha-1 Blockade for Alcohol Use Disorder (AUD)