Alpha-1 Blockade for Alcohol Use Disorder (AUD)

Alcohol Use Disorder (AUD) Clinical Trial

— DOXY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135846
• Other study ID #: 1907002490
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2019
• Est. completion date: December 20, 2024

Study information

• Verified date: July 2023
• Source: Brown University
• Contact: Zoe L Brown, BA
• Phone: 401-863-6646
• Email: alcohol.stress.study[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism

Intervention

Drug:
• Doxazosin
16 mg or maximum tolerated dose (MTD)
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Haass-Koffler CL, Goodyear K, Zywiak WH, Magill M, Eltinge SE, Wallace PM, Long VM, Jayaram-Lindstrom N, Swift RM, Kenna GA, Leggio L. Higher pretreatment blood pressure is associated with greater alcohol drinking reduction in alcohol-dependent individual — View Citation

Kenna GA, Haass-Koffler CL, Zywiak WH, Edwards SM, Brickley MB, Swift RM, Leggio L. Role of the alpha1 blocker doxazosin in alcoholism: a proof-of-concept randomized controlled trial. Addict Biol. 2016 Jul;21(4):904-14. doi: 10.1111/adb.12275. Epub 2015 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)	6 weeks
Secondary	Alcohol craving	We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity	one day
Secondary	Alcohol craving	Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)	six weeks