Using Prazosin to treat alcohol withdrawal symptoms in patients with Alcohol Use Disorder

Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms

This study is testing if the medication Prazosin can help people with Alcohol Use Disorder feel better during withdrawal compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 2 sites (New Haven, Connecticut and 1 other locations)
• Trial ID: NCT04793685 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the effectiveness of Prazosin, administered at a dose of 16 mg/day, compared to a placebo over a 12-week period for individuals with Alcohol Use Disorder (AUD) experiencing withdrawal symptoms. Participants will be randomly assigned to receive either Prazosin or placebo, with a two-week titration period followed by a tapering phase. All subjects will receive weekly behavioral counseling to support their recovery, and outcomes will be measured based on drinking behaviors and psychological symptoms. Follow-up assessments will occur at one and three months post-treatment to evaluate long-term effects.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe Alcohol Use Disorder who exhibit at least three withdrawal symptoms.

Not a fit: Patients with current substance use disorders involving other psychoactive substances or those with a history of opioid use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce heavy drinking days and improve overall recovery outcomes for patients with Alcohol Use Disorder.

How similar studies have performed: While this approach is novel in the context of treating alcohol withdrawal symptoms, similar studies have shown promise in using Prazosin for other conditions, suggesting potential for success.

Eligibility criteria

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).

Where this trial is running

New Haven, Connecticut and 1 other locations

• The Yale Stress Center: Yale University — New Haven, Connecticut, United States (Recruiting)
• The Yale Stress Center: Yale University — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: RAJITA SINHA, PhD

Conditions Alcohol Withdrawal