Low-dose Buprenorphine Initiation for Opioid Use Disorder

Description

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

Conditions

Opioid Use Disorder

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Study Overview

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Study Details

Study overview

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

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

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Use of FDA-approved medications for opioid use disorder treatment (within 14 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Benjamin T Hayes, MD, MS, MPH, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2027-11