RecruitingPhase 2NCT06441604

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

Sponsor

Brigham and Women's Hospital

Enrollment

30 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria13

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.

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Interventions

DRUGExtended-release Buprenorphine

The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.