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Search / Trial NCT05644587

Novel Induction to Buprenorphine/Naloxone

Launched by BICYCLE HEALTH · Nov 30, 2022

Trial Information

Current as of February 05, 2025

Terminated

Keywords

Opioid Opioid Use Disorder Buprenorphine Microdosing

ClinConnect Summary

Medication for OUD (MOUD) is a first-line treatment for OUD and improves outcomes in mortality, retention in treatment, and non-prescribed opioid use. Buprenorphine/naloxone is the only MOUD of the three FDA-approved medications for OUD available in the telehealth setting, as methadone and injectable naltrexone must be managed in an in-person setting. Buprenorphine/naloxone, also referred to as brand name Suboxone, is administered by placing a film strip under the tongue. Buprenorphine acts as a partial agonist with a high binding affinity at the mu-opioid receptor; clearance of the pure op...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Enrollment with Bicycle Health services
  • Aged 18 years old or older
  • Diagnosis of opioid use disorder confirmed by DSM-5 criteria
  • In no/mild withdrawal at the time of intake
  • Need to undergo induction to buprenorphine from a full opioid agonist
  • Use of full opioid agonists not directly from a pharmacy within the last 24 hours
  • Pharmacy stock check of 2 mg film/tablet done before visit
  • Willingness and ability to follow study protocols, and the ability to provide informed consent
  • Exclusion Criteria:
  • Known allergy or sensitivity to buprenorphine/naloxone
  • Any circumstance that precludes the need for induction
  • In moderate to severe withdrawal at the time of intake
  • Severe or complex medical/psychiatric comorbidity that requires a customized induction schedule or surveillance
  • Any element that would exclude an individual from Bicycle Health services in general (e.g., homelessness, severe untreated mental illness)
  • Patients requesting specific induction technique
  • Patients who are pregnant or lactating

Trial Officials

Scott Weiner, MD, MPH

Principal Investigator

Bicycle Health

About Bicycle Health

Bicycle Health is a pioneering organization dedicated to transforming the treatment of substance use disorders through innovative, evidence-based approaches. As a clinical trial sponsor, Bicycle Health focuses on developing and testing novel therapeutic interventions that prioritize patient-centered care and accessibility. With a commitment to advancing the understanding of addiction and enhancing treatment outcomes, the organization collaborates with healthcare professionals and researchers to drive impactful research initiatives. By leveraging cutting-edge technology and a compassionate approach, Bicycle Health aims to improve the lives of individuals affected by substance use disorders and contribute to the broader field of behavioral health.

Locations

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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