Standard Versus High Dose ED-Initiated Buprenorphine Induction
NCT ID: NCT06494904
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-12-06
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High Dose SL-BUP
Participants will receive three 5.7 mg Zubsolv pills; all will be active medication.
Buprenorphine
All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.
Standard SL-BUP
Participants will receive three pills; one 5.7 mg Zubsolv pill with active medication and two placebo pills.
Buprenorphine
All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.
Interventions
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Buprenorphine
All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Be 18-65 years of age.
2. Be treated in the ED during study screening hours.
3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.
4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
5. Have a urine toxicology test that is positive for opioids.
6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria
1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
2. Have a known hypersensitivity reaction to buprenorphine/naloxone
3. Be actively suicidal or severely cognitively impaired precluding informed consent.
4. Require ongoing prescription for opioid analgesics.
5. Have a physical exam or reported history consistent with severe liver failure
6. Have a positive urine test for methadone and reported use in the past 72 hours
7. Be a prisoner or in police custody at the time of index ED visit.
8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
9. Have prior enrollment in the current study.
10. Receiving MOUD treatment within the past 7 days.
11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
12. Have a respiratory rate \<8 or oxygen saturation \<93%
13. Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days
18 Years
65 Years
ALL
No
Sponsors
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National Drug Abuse Treatment Clinical Trials Network
NETWORK
The Emmes Company, LLC
INDUSTRY
National Institute on Drug Abuse (NIDA)
NIH
Alameda Health System
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Gail D'Onofrio, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Kathryn Hawk
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Highland Hospital
Oakland, California, United States
San Leandro Hospital
San Leandro, California, United States
Maine Medical Center
Portland, Maine, United States
Cooper University Hospital
Camden, New Jersey, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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