Status:
RECRUITING
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
Lead Sponsor:
Brown University
Conditions:
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04135846
Start Date
December 19 2019
End Date
December 20 2025
Last Update
September 22 2025
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 20923