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Search / Trial NCT05262270

Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Mar 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Naltrexone Buprenorphine Extended Release Injectable Naltrexone Extended Release Injectable Buprenorphine Cud Cocaine Cocaine Abuse

ClinConnect Summary

The CURB-2 trial is a research study designed to find out how effective a combination of two medications—extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP)—is in helping people with cocaine use disorder (CUD). This study will last for 8 weeks and involves participants receiving either the active medications or placebo injections (which are inactive treatments that look the same as the real medications) without knowing which one they are getting.

To be eligible for this study, you need to be between 18 and 65 years old and interested in reducing or stopping your cocaine use. It’s important that you can follow the study guidelines and medication instructions. If you join, you can expect regular visits for assessments and injections during the trial. This study is currently recruiting participants, and it aims to help find better treatments for those struggling with cocaine use. If you have any concerns about your health that might affect your participation, the study team will discuss these with you.

Gender

ALL

Eligibility criteria

  • Individuals must meet all of the inclusion criteria and no exclusion criteria in order to be eligible to participate in the study, including but not limited to:
  • Inclusion Criteria:
  • 1. Be 18 to 65 years of age;
  • 2. Be interested in reducing or stopping cocaine use.
  • 3. Be willing to comply with all study procedures and medication instructions.
  • Exclusion Criteria:
  • 1. Have any condition for which, in the opinion of the site investigator or designee, study participation would not be in their best interest or that could prevent, limit, or confound the protocol-specified assessments.

About University Of Texas Southwestern Medical Center

The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.

Locations

Chicago, Illinois, United States

Little Rock, Arkansas, United States

Birmingham, Alabama, United States

Chicago, Illinois, United States

Los Angeles, California, United States

Birmingham, Alabama, United States

Baltimore, Maryland, United States

San Antonio, Texas, United States

Dallas, Texas, United States

Minneapolis, Minnesota, United States

San Francisco, California, United States

Tampa, Florida, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Madhukar Trivedi, MD

Principal Investigator

UT Southwestern Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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