Clinical trial NCT04283500: Buprenorphine Loading in the Emergency Department
Official title: Buprenorphine Loading in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid-use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Emergency Medicine Foundation
First posted: 2020-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: A novel induction strategy, in which a loading dose of Buprenorphine (BUP) 32mg is administered, has the potential to mitigate barriers to treatment initiation. ED providers can treat patients with BUP for opioid withdrawal since DEA registration (X-waiver) is not required unless they wish to issue a prescription. Current BUP induction protocols, developed for inpatient and ambulatory care settings as well as for unobserved self- administration via prescription, usually recommend a first day dose of 8mg given in divided doses of 2- 4mg. However, patients discharged with ≤ 8mg SL total dose may experience return of withdrawal symptoms and/or opioid craving within only 4 hours.Treatment with a loading dose of 32mg in the ED may provide the necessary bridge treatment, relieving symptoms of withdrawal until a patient is able to attend a follow up appointment for further treatment.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Successful Rapid Induction
timeFrame: Day 0
Secondary outcomes:
measure: Opioid Withdrawal at Conclusion of Index Visit as Measured by the Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Index ED Visit 1(Day 0)
measure: Number of Participants With Withdrawal Suppresion at Day 1 (24 Hours)
timeFrame: Day 1 (24 hours)
measure: Number of Participants With Withdrawal Suppresion by Day 2
timeFrame: Day 2
measure: Number of Participants With Withdrawal Suppression on Day 3
timeFrame: Day 3
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone
name: Ryan McCormack, MD
role: PRINCIPAL_INVESTIGATOR
References: