Recruiting

Buprenorphine

Sponsor:

Montefiore Medical Center

Code:

NCT05450718

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

buprenorphine-naloxone

buprenorphine-naloxone

Study Details

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

Study ID

NCT05450718

Start date

Nov 11, 2024

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-dose initiation

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

active comparator: Treatment as usual

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

Interventions

buprenorphine-naloxone

Low-dose initiation of buprenorphine-naloxone protocol

buprenorphine-naloxone

Standard clinical guidelines for a two-day buprenorphine-naloxone initiation

Primary outcome measure

  • Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial. [ Time Frame: At baseline study visit (time zero) ]

Central Contacts and Locations

Central contacts

Benjamin T Hayes, MD, MS, MPH

4156700850bhayes@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Benjamin T Hayes, MD, MS, MPH

929-996-3408bhayes@montefiore.org

Jessica Carter

718-920-5394

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • micro-induction
  • microdosing
  • low-dose initiation
  • buprenorphine
  • micro-initiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-21.