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TERMINATED
NCT05118204
PHASE4

Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2022-09-29

Completion Date

2025-04-09

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

DRUG

BUP microdose induction

Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists). Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours

DRUG

TAU

2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours

BEHAVIORAL

Linkage to outpatient BUP treatment

Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States