Phase
Condition
Opioid Use Disorder
Treatment
CAM2038
Buprenorphine Sublingual Product
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
RCT Component:
Inclusion Criteria:
Be 18 years or older
Treated in the ED during study screening hours
Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate tosevere OUD
Have a COWS score of > or equal to 4
Have a urine toxicology test that is positive for opioids (opiates, oxycodone,buprenorphine). Patients with urines that are only positive for fentanyl will beeligible if their clinical history and physical exam are consistent with opioid useand they meet DSM-5 criteria for moderate to severe OUD.
Able to speak English sufficiently to understand the study the study procedures andprovide written informed consent to participate in the study. (Exception may be madeif sites with large population of Spanish speaking patients are accepted forparticipation in the study and study materials are translated into Spanish.Translated study materials will be reviewed and approved by the Institutional ReviewBoard) IRB of record prior to use.)
Exclusion
Exclusion Criteria:
Have urine toxicology test that is positive for methadone
Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the indexED visit
Have a medical or psychiatric condition that requires hospitalization
Opioid administration (excluding BUP) at the index ED visit, prior to enrollment,and COWS remains < 8 during ED stay
Be actively suicidal or severely cognitively impaired precluding informed consent
Present from an extended care facility (e.g., skilled nursing facility)
Require continued prescription opioids for a pain condition
Be a prisoner or in police custody at the time of index ED visit
Be currently (anytime within the past 14 days) enrolled in formal addictiontreatment, including by court order. Patients enrolled in formal addiction who arenot receiving MOUD are eligible
Be unable to provide reliable locator information including 2 contact numbers inaddition to their own
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 component
Ancillary Component:
Inclusion Criteria:
Be 18 years or older
Treated in the ED during study screening hours
Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
Have a COWS <8
Have a urine toxicology test that is positive for opioids (opiates, oxycodone, orbuprenorphine). Patients with urines that are only positive for fentanyl on thepoint of care test strip will be eligible if their clinical history and physicalexam are consistent with opioid use and they meet DSM-5 criteria for moderate tosevere OUD.
Be able to speak English sufficiently to understand the study procedures and providewritten informed consent to participate in the study
Exclusion Criteria:
Have a urine toxicology test that is positive for methadone
Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the indexED visit
Have a medical or psychiatric condition that requires hospitalization at the indexED visit, prior to enrollment
Be actively suicidal or severely cognitively impaired precluding informed consent
Present from an extended care facility (e.g., skilled nursing facility)
Require continued prescription opioids for a pain condition
Be a prisoner or in police custody at the time of index ED visit
Be currently (anytime within the past 7 days) enrolled in formal addictiontreatment, including by court order. Patients enrolled in formal addiction treatmentbut are not receiving MOUD are eligible
Be unable to provide reliable locator information including 2 contact numbers inaddition to their own
Be unwilling to follow study procedures (e.g., unwilling to provide permission toanswer daily assessments until day 7)
Have prior enrollment in the current study
Study Design
Study Description
Connect with a study center
Valleywise Health
Phoenix, Arizona 85006
United StatesSite Not Available
Highland Hospital
Oakland, California 94602
United StatesSite Not Available
San Leandro Hospital
San Leandro, California 94578
United StatesSite Not Available
Yale New Haven Health (Yale New Haven Hospital)
New Haven, Connecticut 06510
United StatesSite Not Available
Jackson Memorial Hospital
Miami, Florida 33136
United StatesSite Not Available
Tampa General Hospital
Tampa, Florida 33606
United StatesSite Not Available
Grady Memorial Hospital
Atlanta, Georgia 30303
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago Medicine
Chicago, Illinois 60637
United StatesSite Not Available
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Detroit Receiving Hospital
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesSite Not Available
Barnes Jewish Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United StatesSite Not Available
Cooper University Hospital
Camden, New Jersey 08103
United StatesSite Not Available
Presybterian Hospital, Albuquerque, NM
Albuquerque, New Mexico 87106
United StatesSite Not Available
University of New Mexico Hospital
Albuquerque, New Mexico 87106
United StatesSite Not Available
Bellevue Hospital
New York, New York 10016
United StatesSite Not Available
Columbia University Irving Medical Center- NY Presbyterian
New York, New York 10032
United StatesSite Not Available
Icahn School of Medicine
New York, New York 10029
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forest School of Medicine
Winston-Salem, North Carolina 27101
United StatesSite Not Available
Pennsylvania Presbyterian Medical Center/Hospital of UPENN
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania 19125
United StatesSite Not Available
UPMC Mercy Hospital
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available
Rhode Island Hospital/The Miriam Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Parkland Memorial Hospital
Dallas, Texas 75235
United StatesSite Not Available
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Washington Medical Center- Harborview/Montlake
Seattle, Washington 98195
United StatesSite Not Available
West Virginia University - Berkeley Medical Center
Martinsburg, West Virginia 25401
United StatesSite Not Available
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