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Emergency Department-Initiated Medications for Alcohol Use Disorder

StatusRecruiting
PhasePhase 3
Started2024-08-17
View on ClinicalTrials.gov ↗

Amendment history

2026-07-18
Study Status v8
Primary completion date2027-12-01→2028-08-01
Completion date2028-03-01→2029-02-01
2025-05-15
Study Status v7
Re-verified, no change to tracked fields
2024-10-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-01→confirmed 2024-08-17
Study sitesdetails revised at 1 of 1 site
2024-07-30
Study Status v5
Start date2024-06-01→2024-09-01
2024-05-22
Study Status, Oversight, Arms and Interventions v4
Primary completion date2027-05→2027-12-01
Completion date2027-05→2028-03-01
Start date2024-05→2024-06-01
Show 3 earlier versions
2024-04-22
Study Status, Eligibility v3
Start date2024-03→2024-05
Eligibility criteria+87 characters
[...] nrolled in this study or currently enrolled in another study. for which they are currently receiving study medications or active ongoing intervention Any contraindication to naltrexone or gabapentin, including [...]
2024-02-07
Study Status, Eligibility v2
Primary completion date2027-04→2027-05
Completion date2027-04→2027-05
Start date2023-11→2024-03
Eligibility criteria+301 characters
Inclusion Criteria: Between 18 and 80 years in age Diagnosed with moderate to severe Alcohol Use Disorder, not in remission. Stated willingness and ability to comply with all study pro [...] ovide written informed consent to participate in the study. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4. Exclusion Criteria: A current diagnosis of OUD, self-reported recentpast 7 day opioid or opioid pain medication use, or a positive urine opioid screen (morphineopiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl) Current prescription of opioid pain medications, or anticipated n [...] [...]
2023-09-14
Study Status v1
Start date2023-07→2023-11
2023-04-12
Original filing
Yale University
487 trials monitored
See 35 trials at risk
The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD). The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive. The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.
Trial Details
NCT Number NCT05827159
Lead Sponsor Yale University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder
Enrollment 240 participants
Start Date 2024-08-17
Primary Completion 2028-08-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-21