NCT05118204

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 31, 2025

Completed
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

September 23, 2021

Results QC Date

October 21, 2025

Last Update Submit

October 21, 2025

Conditions

Substance Use DisordersOpioid-use DisorderChronic Pain

Outcome Measures

Primary Outcomes (1)

  • BUP Treatment Uptake

    The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.

    7 days

Secondary Outcomes (4)

  • Illicit Opioid Use

    1, 3, and 6 months

  • BUP Retention in Care

    1, 3, and 6 months

  • Pain Intensity

    3 months

  • Pain Interference

    3 months

Study Arms (2)

BUP microdose induction

EXPERIMENTAL

Participants in this arm will receive a novel BUP microdose induction protocol.

Drug: BUP microdose inductionBehavioral: Linkage to outpatient BUP treatment

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Participants in this arm will receive standard BUP induction protocol.

Drug: TAUBehavioral: Linkage to outpatient BUP treatment

Interventions

BUP microdose inductionDRUG

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

BUP microdose induction
TAUDRUG

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

Treatment As Usual (TAU)
Linkage to outpatient BUP treatmentBEHAVIORAL

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

BUP microdose inductionTreatment As Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related DisordersChronic Pain

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Aaron Fox
Organization
Albert Einstein College of Medicine
adfox@montefiore.org
718-920-7173

Study Officials

  • Aaron Fox, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

November 11, 2021

Study Start

September 29, 2022

Primary Completion

October 23, 2024

Study Completion

April 9, 2025

Last Updated

October 31, 2025

Results First Posted

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)