RECRUITING

Standard Versus High Dose ED-Initiated Buprenorphine Induction

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Conditions

Opioid Use DisorderBuprenorphineSubstance use disorder treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

ED-Initiated Standard Versus High Dose Buprenorphine Induction

Quick Facts

Study Start:2024-12-06
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06494904

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be 18-65 years of age.
  2. 2. Be treated in the ED during study screening hours.
  3. 3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.
  4. 4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
  5. 5. Have a urine toxicology test that is positive for opioids.
  6. 6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
  1. 1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
  2. 2. Have a known hypersensitivity reaction to buprenorphine/naloxone
  3. 3. Be actively suicidal or severely cognitively impaired precluding informed consent.
  4. 4. Require ongoing prescription for opioid analgesics.
  5. 5. Have a physical exam or reported history consistent with severe liver failure
  6. 6. Have a positive urine test for methadone and reported use in the past 72 hours
  7. 7. Be a prisoner or in police custody at the time of index ED visit.
  8. 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. 9. Have prior enrollment in the current study.
  10. 10. Receiving MOUD treatment within the past 7 days.
  11. 11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
  12. 12. Have a respiratory rate \<8 or oxygen saturation \<93%
  13. 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

Contacts and Locations

Study Contact

Gail D'Onofrio, MD, MS
CONTACT
2037857059
gail.donofrio@yale.edu
Kathryn Hawk, MD, MHS
CONTACT
2037857899
kathryn.hawk@yale.edu

Principal Investigator

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

Study Locations (Sites)

Highland Hospital
Oakland, California, 94602
United States
San Leandro Hospital
San Leandro, California, 94578
United States
Maine Medical Center
Portland, Maine, 04102
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Yale University

  • Gail D'Onofrio, MD, MS, PRINCIPAL_INVESTIGATOR, Yale University
  • Kathryn Hawk, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Buprenorphine
  • Substance use disorder treatment

Additional Relevant MeSH Terms

  • Opioid Use Disorder