Low-dose Buprenorphine Initiation for Opioid Use Disorder

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05450718
Phase
PHASE4
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

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

Interventions

  • buprenorphine-naloxone — DRUG
    Low-dose initiation of buprenorphine-naloxone protocol
  • buprenorphine-naloxone — DRUG
    Standard clinical guidelines for a two-day buprenorphine-naloxone initiation

Study Details

The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

Key Dates

Start date
Nov 11, 2024
Status verified
Sep 2025
Primary completion
Mar 17, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose initiation
    Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours
  • Active Comparator: Treatment as usual
    Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.

Primary Outcome Measure

Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial. [ Time Frame: At baseline study visit (time zero) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Benjamin T Hayes, MD, MS, MPH
[email protected]
929-996-3408
Jessica Carter
718-920-5394

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