Trials
Search / Trial NCT06441604

Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jun 1, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Opioid Use Disorder Buprenorphine

ClinConnect Summary

The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (s...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • English speaking adults aged 18 and above.
  • DSM-5 diagnosis of opioid use disorder.
  • Self-reporting use of illicit opioids in \>21 days in the prior 30 days.
  • Provide urine toxicology testing positive for fentanyl at baseline.
  • Exclusion Criteria:
  • Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
  • Received buprenorphine or methadone treatment in prior 30 days.
  • Current DSM-5 diagnosis of alcohol or sedative/hypnotic use disorder.
  • Physical dependence on alcohol or sedative/hypnotics.
  • Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed Consent.
  • Requiring treatment with opioids for acute or chronic pain.
  • History of hypersensitivity or allergy to buprenorphine or fentanyl.
  • Pregnant or breastfeeding.

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0