RECRUITING

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

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Conditions

Alcohol Use Disorder (AUD)Alcohol use disorder, stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-19
Study Completion:2025-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04135846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, 18 years of age
  2. * Meet the DSM-5 criteria for AUD
  3. * Desire to reduce or quit alcohol drinking
  4. * Breath alcohol (BrAC) = 0.00 at each visit
  5. * In good health as confirmed by medical history, physical examination and lab tests
  6. * Willing to adhere to the study procedures
  7. * Understand informed consent and questionnaires in English at an 8th grade level
  1. * Women who are breastfeeding or /positive urine test for pregnancy
  2. * CrCl\<60mL/min
  3. * Suicide attempt in the last three months
  4. * Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline
  5. * Current use of medication that may interact with doxazosin and/or yohimbine
  6. * History of allergy to any alpha receptor blockers
  7. * Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8
  8. * Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening
  9. * Treatment with any alpha-blocker
  10. * Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG.
  11. * Baseline hypotension defined as BP reading lower than 90/60 mmHg
  12. * Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication

Contacts and Locations

Study Contact

Zoe L Brown, BA
CONTACT
401-863-6646
alcohol.stress.study@brown.edu

Principal Investigator

Carolina L Haass-Koffler, PHARMD, PHD
PRINCIPAL_INVESTIGATOR
Brown University

Study Locations (Sites)

Brown University
Providence, Rhode Island, 20923
United States

Collaborators and Investigators

Sponsor: Brown University

  • Carolina L Haass-Koffler, PHARMD, PHD, PRINCIPAL_INVESTIGATOR, Brown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-19
Study Completion Date2025-12-20

Study Record Updates

Study Start Date2019-12-19
Study Completion Date2025-12-20

Terms related to this study

Keywords Provided by Researchers

  • Alcohol use disorder, stress

Additional Relevant MeSH Terms

  • Alcohol Use Disorder (AUD)