COMPLETED

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

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Conditions

Cocaine Use DisorderNaltrexoneBuprenorphineExtended release injectable NaltrexoneExtended release injectable BuprenorphineCUDCocaineCocaine Abuse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

Official Title

Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Quick Facts

Study Start:2023-04-18
Study Completion:2025-07-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05262270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be 18 to 65 years of age;
  2. 2. Be interested in reducing or stopping cocaine use.
  3. 3. Be willing to comply with all study procedures and medication instructions.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Madhukar Trivedi, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35209
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
UCLA Vine Street Clinic
Los Angeles, California, 90038
United States
Center on Substance Use and Health (CSUH)
San Francisco, California, 94102
United States
Cove Behavioral Health
Tampa, Florida, 33605
United States
University of Illinois at Chicago
Chicago, Illinois, 60608
United States
University of Chicago
Chicago, Illinois, 60637
United States
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
United States
Berman Center for Outcomes and Clinical Research at Hennepin Healthcare
Minneapolis, Minnesota, 55404
United States
Addictions Institute of Mount Sinai
New York, New York, 10029
United States
UTSW Medical Center, Center for Depression Research and Clinical Care
Dallas, Texas, 75247
United States
University of Texas Health San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Madhukar Trivedi, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2025-07-21

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2025-07-21

Terms related to this study

Keywords Provided by Researchers

  • Naltrexone
  • Buprenorphine
  • Extended release injectable Naltrexone
  • Extended release injectable Buprenorphine
  • CUD
  • Cocaine
  • Cocaine Abuse

Additional Relevant MeSH Terms

  • Cocaine Use Disorder