Who is eligible for clinical trial NCT05450718?

Participants must meet protocol criteria for Opioid Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05450718 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-17

Low-dose Buprenorphine Initiation for Opioid Use Disorder (NCT05450718)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Montefiore Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).

Location: Montefiore Medical Center — The Bronx, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Montefiore Medical Center — The Bronx, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗