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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High Dose Buprenorphine
  • Standard Buprenorphine Dose

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rutgers, The State University of New Jersey

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator