Alpha-1 Blockade for Alcohol Use Disorder (AUD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxazosin, Placebo.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD
Overview
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
Interventions
- Drug Doxazosin
16 mg or maximum tolerated dose (MTD) - Drug Placebo
Matching placebo
Primary outcome measures
- Alcohol consumption [Time frame: 6 weeks]
Secondary outcome measures (2)
- Alcohol craving [Time frame: one day]
- Alcohol craving [Time frame: six weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brown University — Providence
Publications
- 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 individuals treated with doxazosin. Drug Alcohol Depend. 2017 Aug 1;177:23-28. doi: 10.1016/j.drugalcdep.2017.03.016. Epub 2017 May 16. PMID 28551590
- 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 Jun 2. PMID 26037245
Identifiers
NCT: NCT04135846 · 1907002490