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Low-dose Buprenorphine Initiation for Opioid Use Disorder

RecruitingPhase 4

A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Montefiore Medical Center · Participants: 70 · Started: Nov 11, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05450718

Locations in the U.S.

New YorkMontefiore Medical Center, The Bronx

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.