Standard Versus High Dose ED-Initiated Buprenorphine Induction

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.

Inclusion criteria

All patients enrolled into the study must:

• Be 18-65 years of age.
• Be treated in the ED during study screening hours.
• Meet DSM-5 diagnostic criteria for moderate to severe OUD.
• Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
• Have a urine toxicology test that is positive for opioids.
• 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:

• Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
• Have a known hypersensitivity reaction to buprenorphine/naloxone
• Be actively suicidal or severely cognitively impaired precluding informed consent.
• Require ongoing prescription for opioid analgesics.
• Have a physical exam or reported history consistent with severe liver failure
• Have a positive urine test for methadone and reported use in the past 72 hours
• Be a prisoner or in police custody at the time of index ED visit.
• Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
• Have prior enrollment in the current study.
• Receiving MOUD treatment within the past 7 days.
• Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
• Have a respiratory rate <8 or oxygen saturation <93%
• 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