NCT06441604 Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
| NCT ID | NCT06441604 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-10-27 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * English speaking adults aged 18 and above. * 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 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. * Liver function test greater than 3 times upper normal limit. * Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06441604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06441604 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06441604 currently recruiting?
Yes, NCT06441604 is actively recruiting participants. Contact the research team at jsuzuki2@bwh.harvard.edu for enrollment information.
Where is the NCT06441604 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06441604 clinical trial?
NCT06441604 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 30 participants.