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NCT04793685 · ClinicalTrials.gov registry record · Phase 2
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
A Phase 2 study of Alcohol Withdrawal, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT04793685: Recruiting Phase 2 study of Alcohol Withdrawal, sponsored by Yale University.
NCT04793685 is a Phase 2 study of Alcohol Withdrawal that is actively recruiting participants, run by Yale University. The registered enrollment target is 150 participants, above the 48-participant average among 3 other Alcohol Withdrawal trials with a reported enrollment target (213% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04793685, a Phase 2 study of Alcohol Withdrawal, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Prazosin
- BEHAVIORAL 12-Step Facilitation with Relapse Prevention and Contingency Management
Study Locations (2)
Connecticut
- The Yale Stress Center: Yale University - New Haven
- The Yale Stress Center: Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT04793685 shows while recruiting
NCT04793685 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 48-participant average among 3 other Alcohol Withdrawal trials with a reported enrollment target (213% higher).
The record links to 1 condition, with Alcohol Withdrawal appearing as the primary indexed condition, and to 2 interventions - of which Prazosin is the first listed.
NCT04793685 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04793685 about?
NCT04793685 is a clinical study titled "Prazosin for Alcohol Use Disorder With 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...
What is the current status of trial NCT04793685?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2021-07-01. Estimated completion is 2027-06-30.
What conditions does trial NCT04793685 study?
This clinical trial studies the following conditions: Alcohol Withdrawal.
What interventions are being tested in trial NCT04793685?
The interventions under investigation include: Prazosin (DRUG), 12-Step Facilitation with Relapse Prevention and Contingency Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT04793685?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04793685 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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