Home › Opioid Overdose › NCT05450718
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
- buprenorphine-naloxone (drug)
- buprenorphine-naloxone (drug)
Sponsor: Montefiore Medical Center · Participants: 70 · Started: Nov 11, 2024
Contact the study team
- Benjamin T Hayes, MD, MS, MPH · Phone: 4156700850
Official record on ClinicalTrials.gov — NCT05450718
Locations in the U.S.
| New York | Montefiore 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.