Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Stopped early · Phase 4

Conditions studied: Substance Use Disorders, Opioid-use Disorder, Chronic Pain

In brief

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.

Key facts

Study ID

NCT05118204

Run by

Montefiore Medical Center

People needed

23

Starts

2022-09-29

Expected to finish

2025-04-09

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Opioid misuse or OUD
• Chronic pain
• Currently taking opioids
• Fluency in English or Spanish
• Planned hospitalization for ≥ 48 hours

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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