Buprenorphine Loading in the Emergency Department

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Buprenorphine (BUP) is FDA-approved for the treatment of opioid withdrawal and opioid use disorder. Few ED providers have received the necessary DEA registration (aka X waiver) required to prescribe BUP, and urgent appointments to continue ongoing BUP treatment may not be readily available, thus leading to medication discontinuity. A loading dose induction strategy with 32mg of BUP may help effectively link ED patients to outpatient treatment while minimizing known barriers to ED uptake. Administering a "loading dose" of BUP to saturate mu-opioid receptors would extend the duration of action and provide additional time to secure ongoing treatment. Further, BUP's ceiling effect on respiratory depression makes it a remarkably safe drug even at high doses. In recent years, ED providers have begun to incorporate this approach into clinical protocols, however, it has not been formally studied in this clinical setting. The investigator's study represents the necessary step of studying this novel approach in the ED setting to define the parameters for clinical protocols and large-scale studies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: Emergency Medicine Foundation
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

• Meets DSM-5 criteria for moderate to severe OUD

• Has a positive urine screen for opioids and a negative urine screen for methadone

• Must be experiencing opioid withdrawal with a COWS score ≥8

• Is willing and able to participate in the study and follow study procedures

• Is able to provide adequate and reliable locator information for follow-up

• Has reliable access to a phone

Exclusion Criteria:

• Is currently engaged in medication treatment for OUD with methadone, BUP, or naltrexone

• Has a urine toxicology test that is positive for methadone or buprenorphine

• Currently requires prescribed opioids for treatment of an ongoing pain condition

• Has a known allergy to BUP

• Is pregnant as determined by urine hCG testing at the index ED visit

• Is breastfeeding as determined by self-report

• Has medical, psychiatric, or concurrent substance use conditions or severe cognitive impairment which might prelude safe participation

• Is a prisoner or in police custody at the time of the index ED visit

• Has previously enrolled in the current study