High Dose BUP Induction in the Emergency Department (ED)

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine

Criteria

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

• COWS score ≥ 8

• Urine toxicology positive for fentanyl

• Able to speak English sufficiently to understand study procedures

Exclusion Criteria:

• UDS positive for methadone.

• Be pregnant determined by HCG 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 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 TM BUP administration

• Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study