Study 44 – Randomized, Placebo-Controlled Trial of Injectable Naltrexone and Monthly Injectable Buprenorphine for Cocaine Use Disorder (CURB-2); CTN-0109

Principal Investigators: Madhukar H. Trivedi, M.D. (University of Texas Southwestern Medical Center), Steve Shoptaw, Ph.D. (University of California, Los Angeles)

Site Investigators: Niranjan Karnik, Ph.D. (University of Illinois, Chicago), Gavin Bart, M.D., Ph.D. (Hennepin Healthcare), Sidarth Wakhlu, M.D. (University of Texas Southwestern Medical Center), Marc Fishman, M.D. (Mountain Manor, Baltimore), Jennifer Papac, M.D. (UT Health San Antonio), Venkat Muvva, M.D. (Cove Behavorial Health), Peter Hendricks, Ph.D. (University of Alabama, Birmingham), Alison Oliveto, Ph.D. (University of Arkansas for Medical Sciences), Jesse Clark, M.D. (University of California, Los Angeles Vine Street Clinic), Phillip Coffin, M.D., Glenn-Milo Santos, Ph.D. (Center for Substance Use and Health, CSUH), Jon E. Grant, M.D. (University of Chicago), Keren Bachi, Ph.D. (Addiction Institute of Mount Sinai)

Release Date: TBA

Description: Cocaine is one of the most commonly abused stimulants globally, and in the US,  there are signs of a resurgence of cocaine use. A variety of pharmacotherapies for cocaine use disorder (CUD) has been explored but so far, no study has findings robust enough to warrant FDA approval. Recent research suggests that a kappa opioid receptor antagonist can curb the negative emotional states associated with stimulant withdrawal that leads to increased craving and drug-seeking behaviors. This protocol builds up on results of the Cocaine Use Reduction with Buprenorphine (CURB) study. It aims to evaluate the safety and efficacy of combined monthly injections of XR-NTX and injectable BUP for CUD compared to placebo.


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