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Alcohol WithdrawalPhase 2NCT04793685

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

A Phase 2 study testing Prazosin and 12-Step Facilitation with Relapse Prevention and Contingency Management in people with Alcohol Withdrawal, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD)… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Alcohol Withdrawal
What is being tested?
Prazosin and 12-Step Facilitation with Relapse Prevention and Contingency Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 30 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Alcohol Withdrawal (AW) scores of 3 or more on the CIWA-Ar at treatment entry OR 2 or more Alcohol Withdrawal Syndrome (AWS) symptoms and regular weekly heavy drinking at treatment entry;
  • Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorder (AUD) using SCID-I for DSM-5;
  • No health conditions that would impact trial participation as verified by screening and physical examination;
  • Able to read English and complete study evaluations
  • Able to provide informed written and verbal consent.

Who cannot join

  • Meet current criteria for moderate to severe substance use disorders from use of any another psychoactive substance, excluding nicotine, cocaine and cannabis;
  • Current use of illicit /non-prescribed opioids more than 2X/month;
  • Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), antiretroviral medications, tricyclic antidepressants, topiramate, baclofen, and regular weekly use of benzodiazepines, as defined by use of three or more times per week;
  • Prescribed use of antihypertensive medications that duplicate the mechanism of action at the alpha1 receptor as prazosin or are contraindicated, such as those medications that are also alpha1-adrenergic antagonists (i.e., doxazosin, tamsulosin, terazosin) or are beta-blockers (e.g., propranolol); Potential participants who are prescribed cardiovascular/antihypertensive medications will undergo clinical review by the study PIs and team. Individuals who are prescribed anti-hypertensives that do not duplicate the action of prazosin and are not contraindicated, including ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, and calcium channel blockers, may be allowed to participate after review from the study physician and principal investigators, with careful monitoring of these individuals' blood pressure at all in-person appointments.
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
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  • Any psychotic disorder or current Axis I psychiatric disorders requiring specific attention, including need for psychiatric medications;
  • Hypotensive individuals with sitting blood pressure below 100/50 mmHG;
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Yale Stress Center: Yale University

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcome will be percent of any heavy drinking days and secondary drinking outcomes will be percent of subjects with no heavy drinking days (PSNHDD), avg drinks per drinking day and %of any drinking drinking days as well as additional secondary outcomes of craving, mood and anxiety problems.

Read the detailed description

In this Phase 2 single site RCT, individuals with moderate to severe alcohol use disorder (AUD) and presence of alcohol withdrawal symptoms (greater than 3 symptoms or more) will be enrolled in a 12 week trial with a 1- and 3- month follow up assessment. Subjects will be randomized to 16 mg /day Prazosin (PR) or Placebo (PBO) with a 2 week titration period and9-week full dose period and week 12 taper. All subjects will be assessed 2X weekly and also provided weekly behavioral counseling to support recovery.

Being tested
Prazosin, 12-Step Facilitation with Relapse Prevention and Contingency Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrazosinDrug

    Also called Minipress

    Prazosin (16mg/day) versus Placebo comparator, with a 2 week titration period, 9 weeks at full dose and a 5-day taper in week 12.

  • 12-Step Facilitation with Relapse Prevention and Contingency ManagementBehavioural

    12-Step Facilitation and relapse prevention weekly support and Contingency Management for each weekly appointment to support treatment attendance for all subjects.

Study groups in NCT04793685
Study groupRoleWhat they receive
Active DrugExperimentalPrazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.
Receives: Drug: Prazosin; Behavioral: 12-Step Facilitation with Relapse Prevention and Contingency Management
Placebo DrugPlacebo comparatorPlacebo for 12 weeks.
Receives: Behavioral: 12-Step Facilitation with Relapse Prevention and Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Heavy Drinking Days

    Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women) after achieving full treatment dose in week 3.

    Measured: weeks 3 - 12 of full dose treatment

Secondary outcomes (2)

  1. Percent Any Drinking Days

    Percent of any drinking days over a 12 week period.

    Measured: after full dose in weeks 3-12 of treatment period

  2. Average Drinks per Drinking Day

    The average number of drinks consumed per drinking day assessed weekly over the treatment period.

    Measured: after full dose in weeks 3-12 treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start1 Jul 2021
  3. Primary completion30 Jan 2026
  4. Study completion30 Jun 2026

Resources

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
Model description
Patients randomized to Prazosin 16 mg/day titrated over 2 weeks versus placebo taken for 12 weeks with week 12 taper of study medications.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04793685
Sponsor's protocol ID
2000029805
Other IDs
R01AA029113-01
Status last verified
Sep 2026
First submitted
3 Mar 2021
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be uploaded to NIAAA data archive (NIAAA-DA housed within the NIMH Data archive (NDa). as per NIH-NIAAA guidelines.

Publications

  • Sinha R, Wemm S, Fogelman N, Milivojevic V, Morgan PM, Angarita GA, Hermes G, Fox HC. Moderation of Prazosin's Efficacy by Alcohol Withdrawal Symptoms. Am J Psychiatry. 2021 May 1;178(5):447-458. doi: 10.1176/appi.ajp.2020.20050609. Epub 2020 Nov 19.

    PubMed 33207935

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prazosin and 12-Step Facilitation with Relapse Prevention and Contingency Management in people with Alcohol Withdrawal, run by Yale 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent Heavy Drinking Days (time frame: weeks 3 - 12 of full dose treatment). 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 NCT04793685, which also lists 1 linked publication.

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 30 Sep 2026.

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