Extended‑release buprenorphine for low‑dose induction in people with opioid use disorder
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
This study will test whether a single injection of extended‑release buprenorphine can safely start treatment in adults with opioid use disorder who are actively using fentanyl without causing precipitated withdrawal.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06441604 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, single‑ascending‑dose, inpatient trial enrolling 30 adults with opioid use disorder who test positive for fentanyl. Participants are admitted for a 3‑day stay during which they will receive controlled doses of fentanyl to prevent withdrawal and then a single injection of extended‑release buprenorphine (XR‑BUP) given when not in withdrawal. The protocol escalates doses in cohorts of 10 (16 mg, then 24 mg, then 32 mg) if at least 90% of the prior cohort avoid precipitated withdrawal. Blood samples for pharmacokinetic analysis will be collected at baseline and at multiple timed points up to 24 hours after injection while clinical staff monitor safety and withdrawal symptoms.
Who should consider this trial
Good fit: Adults (18+) with a diagnosed opioid use disorder who report recent illicit opioid use, test positive for fentanyl, and are willing to stay inpatient for the 3‑day protocol are the ideal candidates.
Not a fit: People currently on or seeking ongoing methadone or sublingual buprenorphine treatment, those with alcohol or sedative/hypnotic use disorder, positive benzodiazepine/methadone screens, or specified serious medical or psychiatric conditions are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, this approach could let people using fentanyl begin buprenorphine treatment with a single injection without waiting for withdrawal, reducing discomfort and barriers to starting medication.
How similar studies have performed: Using extended‑release buprenorphine formulations is an established treatment, but using a single XR injection as a deliberate low‑dose induction in actively fentanyl‑exposed individuals is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Joji Suzuki
- Email: jsuzuki2@bwh.harvard.edu
- Phone: 6177325752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.