Low-dose Buprenorphine Initiation for Opioid Use Disorder

NCT05450718 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2022-141851K23DA055933
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; micro-induction; microdosing; low-dose initiation; buprenorphine; micro-initiation

Outcome Measures

Primary Outcomes (1)

• Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.

  This pilot study is designed to establish the feasibility of a future, full-powered clinical trial. The primary question this study seeks to answer is whether primary care patients with opioid use disorder are willing to enroll in a clinical trial of low-dose inductions. The study will aim to enroll 25% of subjects who are assessed. "Assessed" is defined as having been referred to the study staff. Enrollment is defined as having been randomized to a treatment arm.

  At baseline study visit (time zero)

Secondary Outcomes (7)

• Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.

  From baseline to day 8

• Number of participants who uptake buprenorphine treatment at 2 weeks

  2-week study visit

• Number of participants retained in buprenorphine treatment at 6 weeks

  6-week study visit

• Non-prescribed opioid use

  From baseline to 6-week study visit

• Withdrawal severity

  From baseline to 2-week study visit

Other Outcomes (19)

• Changes in severity of withdrawal scores during buprenorphine initiation buprenorphine initiation

  From baseline to 2-week study visit

• Changes in severity of anxiety scores during buprenorphine initiation

  From baseline to 2-week study visit

• Changes in severity of cravings scores during buprenorphine initiation

  From baseline to 2-week study visit

Study Arms (2)

Low-dose initiation

EXPERIMENTAL

Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours

Drug: buprenorphine-naloxone

Treatment as usual

ACTIVE COMPARATOR

Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.

Drug: buprenorphine-naloxone

Interventions

buprenorphine-naloxone DRUG

Low-dose initiation of buprenorphine-naloxone protocol

Also known as: buprenorphine microdosing, buprenorphine micro-induction, buprenorphine micro-initiation

Low-dose initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Any gender, aged 18 years or greater
• Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
• Ability to take sublingual medication
• Willingness to adhere to the assigned buprenorphine initiation regimen
• Fluency in English or Spanish
• For participants of reproductive potential: agreement to use highly effective contraception during study participation

You may not qualify if:

• Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
• Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
• Severe untreated mental illness, meaning psychosis or suicidality
• Presence of an acute or chronic medical condition that would make participation medically hazardous
• Pregnancy or lactation
• Known allergic reactions to buprenorphine or naloxone
• Inability to consent due to cognitive impairment

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (1)

• Hayes BT, Sabado A, Minami H, Zhang C, Holm M, Khalid L, Lu TY, Torres-Lockhart K, Fox AD. MiBUP: A pilot randomized controlled trial of low-dose initiation of buprenorphine for opioid use disorder: Design and rationale. Contemp Clin Trials Commun. 2026 Jan 5;49:101594. doi: 10.1016/j.conctc.2026.101594. eCollection 2026 Feb.

  PMID: 41567709 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Benjamin T Hayes, MD, MS, MPH

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin T Hayes, MD, MS, MPH

CONTACT

4156700850; bhayes@montefiore.org

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: June 22, 2022
• First Posted: July 11, 2022
• Study Start: November 11, 2024
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months to 5 years following article publication

Locations

US (1)