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NCT04135846PHASE2Recruiting

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

Brown University

Start Date

12/19/2019

Completion Date

8/31/2026

Summary

The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.

Detailed Description

16 week, between-subject, double-blind, randomized clinical trial (RCT) with doxazosin (16 mg, or maximum tolerated dose, MTD) compared to placebo in 184 treatment seeking individuals with AUD

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Male or female, 18 years of age * Meet the DSM-5 criteria for AUD * Desire to reduce or quit alcohol drinking * Breath alcohol (BrAC) = 0.00 at each visit * In good health as confirmed by medical history, physical examination and lab tests * Willing to adhere to the study procedures * Understand informed consent and questionnaires in English at an 8th grade level Exclusion Criteria: * Women who are breastfeeding or /positive urine test for pregnancy * CrCl\<60mL/min * Suicide attempt in the last three months * Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline * Current use of medication that may interact with doxazosin and/or yohimbine * History of allergy to any alpha receptor blockers * Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8 * Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening * Treatment with any alpha-blocker * Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG. * Baseline hypotension defined as BP reading lower than 90/60 mmHg * Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication

Interventions

DRUG

Doxazosin

DRUG

Placebo

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Conditions

Alcohol Use Disorder (AUD)

Locations

Brown University

Providence, Rhode Island 20923

United States