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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06441604
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Extended-release Buprenorphine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 16mg Extended-Release Buprenorphine
    The first 10 participants will receive XR-BUP 16mg in single-blind fashion.
  • Experimental: 24mg Buprenorphine
    After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.
  • Experimental: 32mg Buprenorphine
    After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.

Primary Outcome Measure

Safety and tolerability of XR-Buprenorphine [ Time Frame: For the duration of the inpatient admission, lasting 24 hours after receipt of study drug. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02118-5605
Anika Clinical Research Coordinator
[email protected]
617-525-0676

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By research site
Brigham and Women's Hospital· Boston, MA

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