Alpha-1 Blockade for Alcohol Use Disorder (AUD)

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder (AUD)
• Interventions: Drug: Placebo; Drug: Doxazosin

• Registration Number: NCT04135846
• Lead Sponsor: Brown University

Brief 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

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2019-12-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	matching placebo
doxazosin	Doxazosin	16 mg, or maximum tolerated dose (MTD)

Primary Outcome Measures

Name	Time	Method
Alcohol consumption	6 weeks	Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)

Secondary Outcome Measures

Name	Time	Method
Alcohol craving	six weeks	Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States