Low-dose Buprenorphine Initiation for Opioid Use Disorder

This study is testing if a low-dose way to start buprenorphine-naloxone (a medication for opioid use disorder) is safe and works well. You could join if you are 18 or older, have Opioid Use Disorder, and can take medicine under your tongue. The study will compare this low-dose approach to the standard way of starting buprenorphine-naloxone over two days. The main goal is to see how many people who are assessed actually join the study. The current status of this study is unclear, and it plans to enroll about 70 people.

Study design
This is an interventional study that will randomly assign participants to one of two treatment groups. Approximately 70 participants are planned for enrollment.
What's involved
You would have study visits at the beginning, and then at weeks 2 and 4. You would also use a mobile phone to report information about withdrawal, anxiety, craving, and substance use.
Compensation
Not stated in the trial record.
Follow-up
Participants will have study visits at baseline, week 2, and week 4.

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NCT05450718

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Recruiting
PHASE4Ages 18+InterventionalTreatment
Montefiore Medical Center
~70 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:buprenorphine-naloxone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
Measured over At baseline study visit (time zero)
Opioid Use Disorder
1 sites across 1 states
New York1
  • Benjamin T Hayes, MD, MS, MPH · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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

    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.