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
Conditions
Alcohol Use Disorder (AUD)
Locations
Brown University
Providence, Rhode Island 20923
United States