TerminatedPhase 4

Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Stopped: Difficulty recruiting and enrolling participants

United States23 participantsStarted 2022-09-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

BUP Treatment Uptake

Timeframe: 7 days

Trial details

NCT IDNCT05118204

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-23

Results submitted2025-10-21

View on ClinicalTrials.gov More Substance Use Disorders trials