Recruiting
Phase 3

Buprenorphine

Sponsor:

Yale University

Code:

NCT06494904

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Buprenorphine

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Study ID

NCT06494904

Start date

Dec 6, 2024

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 provide written informed consent to participate in the study.

Exclusion Criteria:

All patients enrolled into the study must not:

1. Have a medical or psychiatric condition that requires hospitalization at the time of index 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 to contact 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 being delivered or the use of an investigational drug or device within the last 30 days

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Highland Hospital

Recruiting

Oakland, California, United States, 94602

Contacts

Principal Investigator:

Andrew Herring, MD

San Leandro Hospital

Recruiting

San Leandro, California, United States, 94578

Contacts

Principal Investigator:

Erik Anderson, MD

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Tania Strout, PhD, RN, MS

Tania.Strout@mainehealth.org

Principal Investigator:

Michael Baumann, MD

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Principal Investigator:

Christopher Jones

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Alyrene Dorey, MD

More Information

Sponsor

Yale University

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Buprenorphine
  • Substance use disorder treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-28.