Alpha-1 Blockade for Alcohol Use Disorder (AUD)

• Status: Recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Treatments: Doxazosin

Criteria

Inclusion Criteria:

• Male or female, 18 to 70 (inclusive) 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