Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (NCT06441604)
🩺 Plain-English Summary (8th-Grade Level)
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (14 items).
Location: Brigham and Women's Hospital — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
- Received buprenorphine or methadone treatment in prior 30 days.
- Current diagnosis of alcohol or sedative/hypnotic use disorder.
- Positive urine drug screen for benzodiazepines, alcohol and or methadone.
- Physical dependence on alcohol or sedative/hypnotics.
- Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.
- Have a history or diagnosis of Intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.
- Recent (within 6 months) head trauma, stroke, or myocardial infarction
- Requiring treatment with opioids for acute or chronic pain.
- History of hypersensitivity or allergy to buprenorphine or fentanyl.
- Pregnant or breastfeeding.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Brigham and Women's Hospital — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.