2,000
Participants
Start Date
July 8, 2020
Primary Completion Date
December 6, 2024
Study Completion Date
December 6, 2024
CAM2038
Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.
Buprenorphine Sublingual Product
"COWS ≥ 8: Patients will receive 4mg of SL-BUP for a COWS score of 8-12 (mild withdrawal). After 30-45 minutes if tolerated and no unanticipated adverse reactions, an additional 4mg can be administered for a total of 8mg in the ED. Patients presenting with moderate-severe withdrawal (COWS \>≥ 13) will receive an initial dose of 8mg SL-BUP. All patients will receive a buprenorphine prescription and instructions for additional BUP doses to allow for up to a dose of 12mg if needed, and for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD (medications for opioid use disorder).~COWS 4-7: Patients will be provided with a uniform set of instructions to guide unobserved (home) induction. They will be prescribed doses of SL-BUP to allow them to take dose up to 12mg in the 24 hours after discharge. All patients will also receive a buprenorphine prescription for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD."
Bellevue Hospital, New York
Icahn School of Medicine, New York
Columbia University Irving Medical Center- NY Presbyterian, New York
Weill Cornell Medical College, New York
Upstate Medical University, Syracuse
UPMC Mercy Hospital, Pittsburgh
Pennsylvania Presbyterian Medical Center/Hospital of UPENN, Philadelphia
Temple University Hospital - Episcopal Campus, Philadelphia
Johns Hopkins Hospital, Baltimore
West Virginia University - Berkeley Medical Center, Martinsburg
Wake Forest School of Medicine, Winston-Salem
Duke University, Durham
Medical University of South Carolina, Charleston
Grady Memorial Hospital, Atlanta
Jackson Memorial Hospital, Miami
Tampa General Hospital, Tampa
Vanderbilt University Medical Center, Nashville
Detroit Receiving Hospital, Detroit
Henry Ford Hospital, Detroit
Hennepin County Medical Center, Minneapolis
Northwestern Memorial Hospital, Chicago
University of Chicago Medicine, Chicago
Barnes Jewish Hospital, St Louis
Parkland Memorial Hospital, Dallas
University of Utah Hospital, Salt Lake City
Presybterian Hospital, Albuquerque, NM, Albuquerque
University of New Mexico Hospital, Albuquerque
San Leandro Hospital, San Leandro
Highland Hospital, Oakland
University of Washington Medical Center- Harborview/Montlake, Seattle
Yale New Haven Health (Yale New Haven Hospital), New Haven
Maine Medical Center, Portland
Dartmouth-Hitchcock Medical Center, Lebanon
Cooper University Hospital, Camden
Rhode Island Hospital/The Miriam Hospital, Providence
National Drug Abuse Treatment Clinical Trials Network
NETWORK
The Emmes Company, LLC
INDUSTRY
Harvard Medical School (HMS and HSDM)
OTHER
University of Pennsylvania
OTHER
NYU Langone Health
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Alameda Health System
OTHER
Weill Medical College of Cornell University
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER