NCT06494904

Standard Versus High Dose ED-Initiated Buprenorphine Induction

ED-Initiated Standard Versus High Dose Buprenorphine Induction

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine	All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.

Timeline

• Start date: 2024-12-06
• Primary completion: 2027-04-01
• Completion: 2028-12-01
• First posted: 2024-07-10
• Last updated: 2025-04-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study