Recruiting
Phase 2

Prazosin with Alcohol

Sponsor:

Yale University

Code:

NCT04793685

Conditions

Alcohol Withdrawal

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Prazosin

12-Step Facilitation with Relapse Prevention and Contingency Management

Study Details

Brief 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) 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.

Conditions

Alcohol Withdrawal

Study ID

NCT04793685

Start date

Jul 1, 2021

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Drug

Prazosin (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.

placebo comparator: Placebo Drug

Placebo for 12 weeks.

Interventions

Prazosin

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 Management

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

Primary outcome measure

  • Percent Heavy Drinking Days [ Time Frame: weeks 3 - 12 of full dose treatment ]

Central Contacts and Locations

Central contacts

RAJITA SINHA, PhD

12038592840rajita.sinha@yale.edu

Rachel Hart, MA

203-641-4922rachel.hart@yale.edu

Locations

The Yale Stress Center: Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Rachel Hart, MS

203-737-4791rachel.hart@yale.edu

RAJITA SINHA

2037375805rajita.sinha@yale.edu

Principal Investigator:

Rajita Sinha, PhD

The Yale Stress Center: Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Rachel Hart, MS

203-737-4791rachel.hart@yale.edu

RAJITA SINHA, PHD

12037375805rajita.sinha@yale.edu

Principal Investigator:

Rajita Sinha, PhD

More Information

Sponsor

Yale University

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-12-11.