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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0