Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

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.

Conditions

• Substance Use Disorders
• Opioid-use Disorder
• Chronic Pain

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Weill Medical College of Cornell University

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Aaron Fox, MD · Montefiore Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-29

Primary Completion

2024-10-23

Completion

2025-04-09

FDA Drug

Yes

Countries

• United States

Study Locations