Actively Recruiting
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
Led by Yale University · Updated on 2025-12-11
150
Participants Needed
2
Research Sites
312 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Current moderate to severe substance use disorders from any psychoactive substance other than nicotine, cocaine, or cannabis
- Use of illicit or non-prescribed opioids more than twice per month
- Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than NSAIDs), antiretroviral medications, tricyclic antidepressants, topiramate, baclofen, or benzodiazepines three or more times per week
- Use of antihypertensive medications that act on the alpha1 receptor like prazosin or contraindicated medications such as certain alpha1-adrenergic antagonists or beta-blockers
- Psychotic or severely disabled psychiatric conditions including suicidal, homicidal, or current mania
- Significant cerebral, renal, thyroid, or cardiac medical conditions that could affect participation or safety
- Any psychotic disorder or Axis I psychiatric disorder requiring specific treatment
- Low blood pressure below 100/50 mmHG when sitting
- Women who are pregnant, nursing, or refuse reliable birth control as assessed during medical evaluation and throughout the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Yale Stress Center: Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
The Yale Stress Center: Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
R
RAJITA SINHA, PhD
CONTACT
R
Rachel Hart, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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