Standard Versus High Dose ED-Initiated Buprenorphine Induction

Last updated: April 23, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

3

Condition

Opioid Use Disorder

Treatment

Buprenorphine

Clinical Study ID

NCT06494904
UG1DA015831
UG1DA015831
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All patients enrolled into the study must:

  1. Be 18-65 years of age.

  2. Be treated in the ED during study screening hours.

  3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.

  4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).

  5. Have a urine toxicology test that is positive for opioids.

  6. Be able to speak English sufficiently to understand the study procedures and providewritten informed consent to participate in the study.

Exclusion

Exclusion Criteria:

All patients enrolled into the study must not:

  1. Have a medical or psychiatric condition that requires hospitalization at the time ofindex ED visit.

  2. Have a known hypersensitivity reaction to buprenorphine/naloxone

  3. Be actively suicidal or severely cognitively impaired precluding informed consent.

  4. Require ongoing prescription for opioid analgesics.

  5. Have a physical exam or reported history consistent with severe liver failure

  6. Have a positive urine test for methadone and reported use in the past 72 hours

  7. Be a prisoner or in police custody at the time of index ED visit.

  8. Be unwilling to follow study procedures (e.g., unwilling to provide permission tocontact referral provider/program or unavailable for the follow-up assessments)

  9. Have prior enrollment in the current study.

  10. Receiving MOUD treatment within the past 7 days.

  11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit

  12. Have a respiratory rate <8 or oxygen saturation <93%

  13. Be a participant in any other clinical trial in which medications are beingdelivered or the use of an investigational drug or device within the last 30 days

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Buprenorphine
Phase: 3
Study Start date:
December 06, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Highland Hospital

    Oakland, California 94602
    United States

    Active - Recruiting

  • San Leandro Hospital

    San Leandro, California 94578
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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