Phase
Condition
Opioid Use Disorder
Treatment
Buprenorphine
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All patients enrolled into the study must:
Be 18-65 years of age.
Be treated in the ED during study screening hours.
Meet DSM-5 diagnostic criteria for moderate to severe OUD.
Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
Have a urine toxicology test that is positive for opioids.
Be able to speak English sufficiently to understand the study procedures and providewritten informed consent to participate in the study.
Exclusion
Exclusion Criteria:
All patients enrolled into the study must not:
Have a medical or psychiatric condition that requires hospitalization at the time ofindex ED visit.
Have a known hypersensitivity reaction to buprenorphine/naloxone
Be actively suicidal or severely cognitively impaired precluding informed consent.
Require ongoing prescription for opioid analgesics.
Have a physical exam or reported history consistent with severe liver failure
Have a positive urine test for methadone and reported use in the past 72 hours
Be a prisoner or in police custody at the time of index ED visit.
Be unwilling to follow study procedures (e.g., unwilling to provide permission tocontact referral provider/program or unavailable for the follow-up assessments)
Have prior enrollment in the current study.
Receiving MOUD treatment within the past 7 days.
Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
Have a respiratory rate <8 or oxygen saturation <93%
Be a participant in any other clinical trial in which medications are beingdelivered or the use of an investigational drug or device within the last 30 days
Study Design
Study Description
Connect with a study center
Highland Hospital
Oakland, California 94602
United StatesActive - Recruiting
San Leandro Hospital
San Leandro, California 94578
United StatesActive - Recruiting
Maine Medical Center
Portland, Maine 04102
United StatesActive - Recruiting
Cooper University Hospital
Camden, New Jersey 08103
United StatesActive - Recruiting
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesActive - Recruiting
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