RECRUITING

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Conditions

Opioid Use Disorder micro-induction microdosing low-dose initiation buprenorphine micro-initiation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-11

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05450718

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Benjamin T Hayes, MD, MS, MPH

CONTACT

4156700850

bhayes@montefiore.org

Principal Investigator

Benjamin T Hayes, MD, MS, MPH

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

opioid use disorder
micro-induction
microdosing
low-dose initiation
buprenorphine
micro-initiation

Additional Relevant MeSH Terms

Opioid Use Disorder