RecruitingPhase 2NCT04135846

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD

Sponsor

Brown University

Enrollment

184 participants

Start Date

Dec 19, 2019

Study Type

INTERVENTIONAL

Conditions

Alcohol Use Disorder (AUD)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria12

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