Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

• Status: Not yet recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center

Criteria

Inclusion Criteria:

• Age > 18 years

• Opioid misuse or OUD

• Chronic pain

• Currently taking opioids

• Fluency in English or Spanish

• Planned hospitalization for ≥ 48 hours

Exclusion Criteria:

• Current OUD treatment (BUP, methadone, naltrexone)

• Severe alcohol or benzodiazepine use disorder

• Hypersensitivity to BUP or naloxone

• Pain due to malignancy

• Severe untreated mental illness (suicidality, psychosis)

• Pregnancy

• Unable to consent due to pain or cognitive impairment