Back to resultsAlpha-1 Blockade for Alcohol Use Disorder (AUD) (DOXY)
Primary Purpose
Alcohol Use Disorder (AUD)
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxazosin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring Alcohol use disorder, stress
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 to 70 (inclusive) 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
Sites / Locations
- Brown UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
doxazosin
placebo
Arm Description
16 mg, or maximum tolerated dose (MTD)
matching placebo
Outcomes
Primary Outcome Measures
Alcohol consumption
Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)
Secondary Outcome Measures
Alcohol craving
We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity
Alcohol craving
Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04135846
Brief Title
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
Acronym
DOXY
Official Title
A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
Alcohol use disorder, stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doxazosin
Arm Type
Experimental
Arm Description
16 mg, or maximum tolerated dose (MTD)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Other Intervention Name(s)
Cardura
Intervention Description
16 mg or maximum tolerated dose (MTD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Alcohol consumption
Description
Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Alcohol craving
Description
We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity
Time Frame
one day
Title
Alcohol craving
Description
Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe L Brown, BA
Phone
401-863-6646
Email
alcohol.stress.study@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina L Haass-Koffler, PHARMD, PHD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
20923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Brown
Phone
401-863-6646
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28551590
Citation
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.
Results Reference
result
PubMed Identifier
26037245
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 Jun 2.
Results Reference
result
Learn more about this trial
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
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