Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05450718

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Led by Montefiore Medical Center · Updated on 2025-09-17

70

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to comply with all study procedures and be available for the study duration
  • Any gender, aged 18 years or older
  • Diagnosis of opioid use disorder based on DSM-5 criteria
  • Ability to take sublingual medication
  • Willingness to follow the assigned buprenorphine initiation regimen
  • Fluency in English or Spanish
  • For those who can become pregnant, agreement to use highly effective contraception during the study
Not Eligible

You will not qualify if you...

  • Use of FDA-approved medications for opioid use disorder treatment within 7 days before screening, including methadone, buprenorphine, or naltrexone
  • Diagnosis of severe alcohol use disorder or severe benzodiazepine use disorder
  • Severe untreated mental illness such as psychosis or suicidality
  • Acute or chronic medical conditions that make participation medically unsafe
  • Pregnancy or breastfeeding
  • Known allergy to buprenorphine or naloxone
  • Inability to consent due to cognitive impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

B

Benjamin T Hayes, MD, MS, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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