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Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

150 Participants Needed

Prazosin for Alcohol Withdrawal

Overseen ByRAJITA SINHA, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Opioids, Anticonvulsants, Antidepressants, others

Disqualifiers: Substance use disorders, Psychotic disorders, others

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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 outcomes will be percent of subjects no heavy drinking days (PSNHDD) and %of any drinking and heavy drinking days as well as secondary outcomes of craving, mood, anxiety and sleep problems.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes people who regularly use anticonvulsants, sedatives, certain pain relievers, and other specific medications. It's important to discuss your current medications with the trial team to see if you qualify.

What data supports the effectiveness of the drug Prazosin for alcohol withdrawal?

Research suggests that Prazosin may help reduce alcohol intake and prevent relapse in people with high alcohol withdrawal symptoms. In a study, Prazosin reduced drinking days and heavy drinking days in patients with significant withdrawal symptoms, and animal studies showed it decreased alcohol consumption in rats.¹ ² ³ ⁴ ⁵

Is prazosin safe for use in humans?

Prazosin is generally considered safe for use in humans, but it can lower blood pressure, especially when combined with alcohol, which may cause dizziness or fainting. It is important to monitor blood pressure and discuss any concerns with a healthcare provider.¹ ⁵ ⁶ ⁷ ⁸

How does the drug prazosin differ from other treatments for alcohol withdrawal?

Prazosin is unique because it targets adrenergic mechanisms (related to the nervous system's response to stress) to reduce alcohol withdrawal symptoms, which may help prevent relapse in people with alcohol use disorder. Unlike some other treatments, prazosin's effectiveness is particularly noted in patients with high alcohol withdrawal symptoms.¹ ² ³ ⁵ ⁷

Research Team

Gretchen Hermes, MD

Principal Investigator

Yale University

David Fiellin, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with moderate to severe Alcohol Use Disorder who experience withdrawal symptoms. Participants must be able to read English, have no other substance use disorders (except nicotine), and not be using certain medications like opioids or antihypertensives. They should not have severe psychiatric conditions or significant medical issues that could interfere with the study.

Inclusion Criteria

Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorder (AUD) using SCID-I for DSM-5;

Able to read English and complete study evaluations

Able to provide informed written and verbal consent

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Exclusion Criteria

I do not have a severe mental health condition that needs specific treatment or medication.

Meet current criteria for moderate to severe substance use disorders from use of any another psychoactive substance, excluding nicotine

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)

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Prazosin or Placebo over a 12-week period with a 2-week titration and a 5-day taper, along with weekly behavioral counseling

12 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1 and 3 months post-treatment

3 months

2 visits (in-person)

Treatment Details

Interventions

12-Step Facilitation with Relapse Prevention and Contingency Management
Prazosin

Trial OverviewThe trial tests Prazosin (16mg/day) against a placebo over 12 weeks in patients with Alcohol Use Disorder and withdrawal symptoms. It includes weekly behavioral counseling sessions. The main focus is on reducing heavy drinking days, along with monitoring craving, mood, anxiety, and sleep problems.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active DrugExperimental Treatment2 Interventions

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.

Group II: Placebo DrugPlacebo Group1 Intervention

Placebo for 12 weeks.

Prazosin is already approved in United States for the following indications:

Approved in United States as Minipress for:

Hypertension
Benign prostatic hypertrophy
Posttraumatic stress disorder (PTSD) nightmares and hyperarousal symptoms

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a 12-week study involving 100 adults with alcohol dependence, prazosin significantly reduced heavy drinking days and overall drinking days in participants with high alcohol withdrawal symptoms, compared to those on a placebo.

Prazosin also improved associated symptoms like anxiety, depression, and alcohol craving in individuals experiencing high withdrawal symptoms, suggesting that these symptoms may predict the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderation of Prazosin's Efficacy by Alcohol Withdrawal Symptoms.Sinha, R., Wemm, S., Fogelman, N., et al.[2022]

A recent randomized controlled trial with 100 participants found that prazosin, an α1 adrenoceptor antagonist, significantly reduced drinking days and heavy drinking days in patients with high alcohol withdrawal symptoms (AWS), specifically those with a Clinical Institute Withdrawal Assessment for Alcohol-Revised score of 3 or higher.

The study suggests that targeting high AWS with symptom-driven pharmacological interventions like prazosin may improve treatment outcomes for individuals with alcohol use disorder, although the mixed results from previous trials indicate the need for further research on various medications that could be more effective or better tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prazosin for Alcohol Use Disorder: A Symptom-Driven Approach to the Choice of Intervention.Andrade, C.[2021]

Prazosin effectively prevents the alcohol deprivation effect (ADE) in alcohol-preferring rats, indicating its potential to reduce relapse in alcohol consumption after periods of abstinence.

In a study involving adult male P rats, prazosin administration abolished the expected increase in alcohol intake following alcohol deprivation, suggesting it may be a promising treatment for preventing relapse in individuals with alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prazosin Reduces Alcohol Intake in an Animal Model of Alcohol Relapse.Froehlich, JC., Hausauer, B., Fischer, S., et al.[2019]