427
Participants
Start Date
April 18, 2023
Primary Completion Date
June 27, 2025
Study Completion Date
July 21, 2025
Extended-Release Naltrexone
XR-NTX (Extended-Release Naltrexone) doses of 380mg (Weeks 0, 3 and 6) via intramuscular (IM) injections in the gluteus.
Extended Release Buprenorphine
Extended-Release buprenorphine (XR-BUP) two doses of 300mg XR-BUP (Weeks 0, 4) via subcutaneous injections in the abdomen. Option for 100mg at Weeks 3 and 6 (if needed to alleviate side effects).
Placebo (PLB) Injectable matched to XR-NTX
3 doses of intramuscular injections (Week 0, 3, 6)
Placebo (PLB) Injectable matched to XR-BUP
2 doses of subcutaneous injections (Week 0, 4)
Addictions Institute of Mount Sinai, New York
Mountain Manor Treatment Center, Baltimore
Cove Behavioral Health, Tampa
University of Alabama at Birmingham, Birmingham
Berman Center for Outcomes and Clinical Research at Hennepin Healthcare, Minneapolis
University of Illinois at Chicago, Chicago
University of Chicago, Chicago
University of Arkansas for Medical Sciences, Little Rock
UTSW Medical Center, Center for Depression Research and Clinical Care, Dallas
University of Texas Health San Antonio, San Antonio
UCLA Vine Street Clinic, Los Angeles
Center on Substance Use and Health (CSUH), San Francisco
National Institute on Drug Abuse (NIDA)
NIH
University of Texas Southwestern Medical Center
OTHER