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Standard Versus High Dose ED-Initiated Buprenorphine Induction

Study acronym: ED-ENVISION
StatusRecruiting
PhasePhase 3
Started2024-12-06
View on ClinicalTrials.gov ↗

Amendment history

2026-05-27
Study Status v5
Primary completion date2027-04→2027-09
2025-04-23
Study Status v4
Re-verified, no change to tracked fields
2025-02-11
Study Status, Contacts/Locations, IPDSharing v3
Study sitesdetails revised at 2 of 5 sites
2025-01-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2024-12-06
Study sitesdetails revised at 5 of 5 sites
2024-10-31
Study Identification, Study Status, Oversight, Eligibility, IPDSharing v1
Primary completion date2027-02→2027-04
Completion date2028-10→2028-12
Start date2024-08→2024-11
Eligibility criteria+576 characters
Inclusion Criteria: All patients enrolled into the study must: Be 18-65 years orof olderage. Be treated in the ED during study screening hours. Meet DS [...] cal Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment). Have a urine toxicology test that is positive for opioids. [...] hat requires hospitalization at the time of index ED visit. Have a known hypersensitivity reaction to buprenorphine/naloxone Be actively suicidal or severely cognitively impaired preclu [...] onsent. Require ongoing prescription for opioid analgesics. Have a physical exam or re [...] [...]
2024-07-02
Original filing
Yale University
487 trials monitored
See 35 trials at risk
This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.
Trial Details
NCT Number NCT06494904
Lead Sponsor Yale University
Collaborators: National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA), Alameda Health System
Conditions Opioid Use Disorder
Enrollment 360 participants
Start Date 2024-12-06
Primary Completion 2027-09 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28