Recruiting
Phase 3

Buprenorphine

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05589181

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Dose Buprenorphine

Standard Buprenorphine Dose

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Study ID

NCT05589181

Start date

Apr 6, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
  • Treated in the ED during screening hours
  • Meet DSM-5 diagnostic criteria for moderate to severe OUD
  • Clinical Opioid Withdrawal Score (COWS) score ≥ 8
  • Urine toxicology positive for fentanyl
  • Able to speak English or Spanish sufficiently to understand study procedures

Exclusion Criteria:

  • UDS positive for methadone.
  • Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing
  • Have an unstable medical or psychiatric condition including suicidality requiring hospitalization
  • Require ongoing opioids for pain management
  • Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible
  • Be a prisoner or in custody at the time of the index visit
  • Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.
  • Unable to provide one additional point of contact other than themselves
  • Unwilling to follow study procedures
  • Have prior enrollment in the current study
  • Have a known allergy or hypersensitivity to BUP
  • Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA)
  • Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration
  • Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

High Dose Buprenorphine

32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose

Standard Buprenorphine Dose

12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg 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 and Locations

Central contacts

Ethan Cowan, MD, MS

(917) 447-4964ethan.cowan@rutgers.edu

Clare O'Brien-Lambert

co442@njms.rutgers.edu

Locations

Rutgers University Hospital

Recruiting

Newark, New Jersey, United States, 07103

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-30.