Standard Versus High Dose ED-Initiated Buprenorphine Induction

Description

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Conditions

Opioid Use Disorder

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Study Overview

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Study Details

Study overview

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

ED-Initiated Standard Versus High Dose Buprenorphine Induction

Standard Versus High Dose ED-Initiated Buprenorphine Induction

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Oakland

Highland Hospital, Oakland, California, United States, 94602

San Leandro

San Leandro Hospital, San Leandro, California, United States, 94578

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Camden

Cooper University Hospital, Camden, New Jersey, United States, 08103

Salt Lake City

University of Utah Hospital, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Gail D'Onofrio, MD, MS, PRINCIPAL_INVESTIGATOR, Yale University

Kathryn Hawk, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2028-12