Alcohol Use Disorder (AUD)Phase 2DOXYNCT04135846
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
A Phase 2 study testing Doxazosin in people with Alcohol Use Disorder (AUD), run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Doxazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD
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.
Read the 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
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Doxazosin, Placebo
- Keywords
- Alcohol use disorder, stress
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxazosinDrug
Also called Cardura
16 mg or maximum tolerated dose (MTD)
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| doxazosin | Experimental | 16 mg, or maximum tolerated dose (MTD) Receives: Drug: Doxazosin |
| placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)
Measured: 6 weeks
Secondary outcomes (2)
Alcohol craving
We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity
Measured: one day
Alcohol craving
Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start19 Aug 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina L Haass-Koffler, Brown University
- Investigators
- Carolina L Haass-Koffler, PHARMD, PHD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135846
- Sponsor's protocol ID
- 1907002490
- Acronym
- DOXY
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28551590Kenna 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.
PubMed 26037245
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD
- ClinicalTrials.gov ID
- NCT04135846
- Acronym / sponsor ID
- DOXY / 1907002490
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol use disorder, stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxazosin | Experimental | Drug: Doxazosin16 mg, or maximum tolerated dose (MTD) |
| placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxazosinAlso: Cardura16 mg or maximum tolerated dose (MTD) | Drug | doxazosin |
| PlaceboMatching placebo | Drug | placebo |
Primary outcome
Alcohol consumption
Time frame: 6 weeks
Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)
2 secondary outcomes
Alcohol craving
Time frame: one day
Alcohol craving
Time frame: six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Results publication: PubMed 28551590Haass-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 publication: PubMed 26037245Kenna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina L Haass-Koffler, PHARMD, PHD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxazosin in people with Alcohol Use Disorder (AUD), run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135846, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.