High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05589181
Phase
PHASE3
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

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

Interventions

  • High Dose Buprenorphine — DRUG
    32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose
  • Standard Buprenorphine Dose — DRUG
    12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose

Study Details

This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.

Key Dates

Start date
Apr 6, 2023
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Active Comparator: Buprenorphine Standard Dose
    The standard arm will receive an induction dose of 12mg of buprenorphine (BUP) split as 8mg at time=0 and 4mg at time=30-60 min.
  • Experimental: Buprenorphine High Dose
    The experimental arm tests the safety and tolerability of 32mg of BUP split as 16mg at time=0 and 16mg at time=30-60 min as an induction dose.

Primary Outcome Measure

The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction [ Time Frame: 7 days post-ED visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers University HospitalNewarkNew Jersey07103-

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By research site
Rutgers University Hospital· Newark, NJ

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