Standard Versus High Dose ED-Initiated Buprenorphine Induction

Part of paid clinical trials in Oakland, California.

Sponsor
Yale University
Study ID
NCT06494904
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose SL-BUP
    Participants will receive three 5.7 mg Zubsolv pills; all will be active medication.
  • Active Comparator: Standard SL-BUP
    Participants will receive three pills; one 5.7 mg Zubsolv pill with active medication and two placebo pills.

Primary Outcome Measure

Engagement in Treatment (10) [ Time Frame: Within 10 days after study randomization ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Highland HospitalOaklandCalifornia94602
Andrew Herring, MD
[email protected]
510-437-4800
Andrew Herring, MD (PRINCIPAL_INVESTIGATOR)
San Leandro HospitalSan LeandroCalifornia94578
Erik S Anderson, MD
[email protected]
510-437-4970
Erik Anderson, MD (PRINCIPAL_INVESTIGATOR)
Maine Medical CenterPortlandMaine04102
Tania Strout, PhD, RN, MS
[email protected]
Michael Baumann, MD (PRINCIPAL_INVESTIGATOR)
Cooper University HospitalCamdenNew Jersey08103
Christopher Jones, MD
[email protected]
Christopher Jones (PRINCIPAL_INVESTIGATOR)
University of Utah HospitalSalt Lake CityUtah84132
Alyrene Dorey, MD
[email protected]
Alyrene Dorey, MD (PRINCIPAL_INVESTIGATOR)

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Highland Hospital· Oakland, CASan Leandro Hospital· San Leandro, CAMaine Medical Center· Portland, MECooper University Hospital· Camden, NJUniversity of Utah Hospital· Salt Lake City, UT

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