Status:
COMPLETED
Buprenorphine Loading in the Emergency Department
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Emergency Medicine Foundation
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 B...
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 BU...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04283500
Start Date
November 1 2020
End Date
February 25 2023
Last Update
April 15 2024
Active Locations (1)
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1
NYU Langone
New York, New York, United States, 10016