Using doxazosin to treat alcohol use disorder
A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD
This study is testing if doxazosin can help people with Alcohol Use Disorder feel better over 16 weeks compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT04135846 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of doxazosin, an alpha-1 blocker, in treating individuals with Alcohol Use Disorder (AUD) over a 16-week period. It is a double-blind, randomized controlled trial involving 184 participants who are seeking treatment for AUD. The study will compare the effects of doxazosin at a maximum tolerated dose against a placebo, while also investigating the role of stress in the development of AUD. Participants will be monitored for their health and adherence to study protocols throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the DSM-5 criteria for AUD and are motivated to reduce or quit alcohol consumption.
Not a fit: Patients with a recent history of severe substance use disorders, certain medical conditions, or those currently on conflicting medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new pharmacotherapy option for individuals struggling with alcohol use disorder.
How similar studies have performed: Previous pilot trials have shown promising results with similar approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Carolina L Haass-Koffler, PHARMD, PHD — Brown University
- Study coordinator: Zoe L Brown, BA
- Email: alcohol.stress.study@brown.edu
- Phone: 401-863-6646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.