Comparing standard and high doses of buprenorphine for opioid use disorder treatment

ED-Initiated Standard Versus High Dose Buprenorphine Induction

This study is testing whether a standard or higher dose of buprenorphine helps people with opioid use disorder start treatment and feel better within 10 days.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 5 sites (Oakland, California and 4 other locations)
• Trial ID: NCT06494904 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multisite, double-blind, double-dummy, randomized study that aims to enroll emergency department patients with untreated moderate to severe opioid use disorder. It compares the effectiveness of standard dose induction (SDI) versus high dose induction (HDI) of buprenorphine in promoting participation in opioid use disorder treatment within 10 days post-randomization. The study will also evaluate differences in opioid withdrawal symptoms, cravings, and the use of illicit drugs. Approximately four emergency department systems across the U.S. will be involved in recruiting participants for this trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who meet the criteria for moderate to severe opioid use disorder and are currently in an emergency department setting.

Not a fit: Patients with severe medical or psychiatric conditions requiring hospitalization or those with a known hypersensitivity to buprenorphine/naloxone may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment engagement and outcomes for patients with opioid use disorder.

How similar studies have performed: Previous studies have shown promising results with buprenorphine for opioid use disorder, suggesting that this approach may be effective, though the specific comparison of dosing strategies is less commonly tested.

Eligibility criteria

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

Where this trial is running

Oakland, California and 4 other locations

• Highland Hospital — Oakland, California, United States (Recruiting)
• San Leandro Hospital — San Leandro, California, United States (Recruiting)
• Maine Medical Center — Portland, Maine, United States (Recruiting)
• Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
• University of Utah Hospital — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Gail D'Onofrio, MD, MS — Yale University
• Study coordinator: Gail D'Onofrio, MD, MS

Conditions Opioid Use Disorder; Buprenorphine; Substance use disorder treatment