Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04793685 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

StatusCompleted
PhasePhase 2
Started2021-07-01
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Trial completed
Primary completion confirmed: January 2026 (last estimated June 2026)
2025-12-04
Study Status, Study Description, Outcome Measures v8
Secondary endpoints3 to 2 entries
Percent Heavy Drinking Days Average Drinks per Drinking Day
Primary endpoints1 entry, revised
Percent of Subjects with no Heavy Drinking Days
Study description+27 characters
[...] azosin (PR) or Placebo (PBO) with a 2 week titration period and9-week full dose period and week 12 taper. All subjects will be assessed 2X weekly a [...]
2025-10-30
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v7
Eligibility criteria+905 characters
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 useheavy of alcohol at least 3X weekly or moredrinking at treatment entry; Must meet current DSM-5 criteria for mo [...] se of any another psychoactive substance, excluding nicotine, cocaine and cannabis; Current use of illicit /non-prescribed opioids ormore pastthan history of opioid use disorder2X/month; Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than noonnon-steroidal antiinflammato [...] [...]
Study descriptionrevised
In this Phase 2 single site RCT, individuals with moderate to severe alcohol use disorder (AUD) and presencpresence eofof alcohol withdrawal symptoms (greater than 3 symptoms or mor [...] nth follow up assessment. Subjects will be randomized to 16 mhmg /day Prazosin (PR) or Placebo (PBO) with a 2 week titration [...]
Study sitescontacts updated at 2 of 2 sites
2025-02-19
Study Status, Contacts/Locations v6
Completion date2026-06-30→2027-06-30
Study sitescontacts updated at 2 of 2 sites
2025-01-21
Study Identification, Study Status, Sponsor/Collaborators, Study Design v5
PhasePhase 1/2→Phase 2
Completion date2027-06-30→2026-06-30
Collaborators+58 characters
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Show 4 earlier versions
2023-12-19
2 amendments v3-v4
2 re-verifications since 2023-01-10, no change to tracked fields
2022-01-13
Study Identification, Study Status v2
Primary completion date2026-01-15→2026-06-30
Start date2021-07-10→2021-07-01
Study title+25 characters
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
2021-07-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-06-01→confirmed 2021-07-10
Study sites1→2
2021-03-09
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT04793685
Lead Sponsor Yale University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Withdrawal
Enrollment 152 participants
Start Date 2021-07-01
Primary Completion 2026-01-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-30