Low-dose Buprenorphine Initiation for Opioid Use Disorder

Recruiting now · Phase 4

Conditions studied: Opioid Use Disorder

In brief

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

Key facts

Study ID

NCT05450718

Run by

Montefiore Medical Center

People needed

70

Starts

2024-11-11

Expected to finish

2027-06-30

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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