RecruitingPhase 4NCT05450718
Low-dose Buprenorphine Initiation for Opioid Use Disorder
A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
Sponsor
Montefiore Medical Center
Enrollment
70 participants
Start Date
Nov 11, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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
Exclusion Criteria7
- 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
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Interventions
DRUGbuprenorphine-naloxone
Low-dose initiation of buprenorphine-naloxone protocol
DRUGbuprenorphine-naloxone
Standard clinical guidelines for a two-day buprenorphine-naloxone initiation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05450718
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