Actively Recruiting
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Led by Yale University · Updated on 2025-04-25
360
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Drug Abuse Treatment Clinical Trials Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years of age
- Be treated in the emergency department during study screening hours
- Meet DSM-5 criteria for moderate to severe opioid use disorder
- Have a Clinical Opiate Withdrawal Scale (COWS) score of 8 or higher at enrollment, including 2 objective signs of withdrawal
- Have a urine test positive for opioids
- Be able to understand English well enough to provide written informed consent
You will not qualify if you...
- Have a medical or psychiatric condition requiring hospitalization at the emergency department visit
- Have a known allergy or hypersensitivity to buprenorphine/naloxone
- Be actively suicidal or have severe cognitive impairment preventing informed consent
- Require ongoing prescription opioid analgesics
- Have severe liver failure based on physical exam or history
- Have a positive urine test for methadone and reported use within the past 72 hours
- Be a prisoner or in police custody at the time of the emergency department visit
- Be unwilling to follow study procedures or unavailable for follow-up
- Have been previously enrolled in this study
- Have received medications for opioid use disorder within the past 7 days
- Be pregnant as confirmed by hCG testing at the emergency department visit
- Have a respiratory rate less than 8 or oxygen saturation below 93%
- Be participating in another clinical trial involving medications or investigational drugs/devices within the last 30 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Highland Hospital
Oakland, California, United States, 94602
Actively Recruiting
2
San Leandro Hospital
San Leandro, California, United States, 94578
Actively Recruiting
3
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
4
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
5
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
G
Gail D'Onofrio, MD, MS
CONTACT
K
Kathryn Hawk, MD, MHS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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