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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05262270
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : April 22, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Extended-Release Naltrexone Drug: Extended Release Buprenorphine Drug: Placebo (PLB) Injectable matched to XR-NTX Drug: Placebo (PLB) Injectable matched to XR-BUP Phase 2

Detailed Description:

The primary objective of this study is to assess the efficacy of XR-NTX plus XR-BUP as a combination pharmacotherapy for CUD. Approximately four hundred and twenty-six adults will be randomized into the study at 8-12 sites in the U.S. Eligibility will be determined during a maximum 21-day screening period. After screening/baseline is completed and eligibility is confirmed, participants will be randomized and begin the 1-week medication induction phase followed by the 8-week medication phase of the trial.

Participants will be randomized in a 1:1 ratio to either 1) XR-NTX + XR-BUP arm and receive injections of extended-release naltrexone (XR-NTX; as Vivitrol®) and extended-release buprenorphine (XR-BUP; as SublocadeTM), or to 2) PBO-Inj matching the timeline and delivery methods of injections for the XR-NTX + XR-BUP arm. XR-NTX or PBO-Inj injections will be provided on the day of randomization and in Weeks 3 and 6. XR-BUP or PBO-Inj injections will be provided on days 3-5 following randomization and in week 4. During the 1-week induction phase and the 8-week medication phase, participants will be asked to attend clinic twice weekly for collection of urine samples and to complete assessments as indicated on the schedule of assessments. Following the 8-week medication phase, participants will be asked to attend clinic weekly for the follow-up phase during Weeks 9-12.

Participants will be involved in the study for approximately 16 weeks, including a screening/baseline period of up to 3 weeks (i.e., 21 days), 1 week for randomization and medication induction, 8 weeks of medication, and 4 weeks of follow-up. The screening phase may differ by participant in the length of time needed to complete preliminary eligibility assessments. Randomization and medication induction visit may take approximately 2 hours. Twice-weekly visits during the medication phase will range from about 20 to 90 minutes in length depending on scheduled assessments. Medication administration visits may require an additional 2 hours. Visits in the follow-up phase will take place approximately 30-60 minutes to complete. An 8-week medication period was selected based on expected time for group differences to emerge and for pragmatic issues related to medication dosing.

Enrollment is expected to take place over a period of approximately 13 months, with an approximate total of 16 months of study visits.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). XR-NTX is delivered via intramuscular (IM) injection in the gluteus; XR-BUP is delivered via subcutaneous (SQ) injection in the abdomen.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind, placebo-controlled study.
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
Actual Study Start Date : April 18, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug intervention (XR-NTX+XR-BUP)

The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4).

Drug: XR-NTX XR-NTX: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Extended Release Injectable Naltrexone Arm: Experimental

Drug: XR-BUP XR-BUP: 2 subcutaneous injections administered Week 0, 4. Other Names: Extended Release Injectable Buprenorphine Arm: Experimental

 Drug: Extended-Release Naltrexone
XR-NTX (Extended-Release Naltrexone) doses of 380mg (Weeks 0, 3 and 6) via intramuscular (IM) injections in the gluteus.
Other Name: XR-NTX

Drug: 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).
Other Name: XR-BUP
Placebo Comparator: Placebo

Matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

Drug: Placebo (PLB) Injectable Placebo: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Injectable matching (to XR-NTX) placebo Arm: Placebo Comparator - matched Placebo (PLB)

Drug: Placebo (PLB) Injectable Placebo: 2 subcutaneous injections administered Week 0, 4. Other Names: Injectable matching (to XR-BUP) placebo Arm: Placebo Comparator - matched Placebo (PLB)

 Drug: Placebo (PLB) Injectable matched to XR-NTX
3 doses of intramuscular injections (Week 0, 3, 6)
Other Name: Injectable matching (to XR-NTX) placebo

Drug: Placebo (PLB) Injectable matched to XR-BUP
2 doses of subcutaneous injections (Week 0, 4)
Other Name: Injectable matching (to XR-BUP) placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Cocaine-negative UDS [ Time Frame: Week 5 up to Week 8 ]
    The primary outcome measure is the proportion of cocaine-negative UDS obtained during Weeks 5 through 8 of the medication phase as measured for the XR-NTX + XR-BUP and PBO-Inj conditions. The primary outcome (UDS) has been chosen because it is an objective measure of cocaine use and was the outcome showing significant improvement over placebo in the original CURB trial.


Secondary Outcome Measures :
  1. Number of participants who Self-report cocaine use [ Time Frame: 8 Weeks ]
    Self-report elicited through Timeline Followback (TLFB) on days of cocaine use during Weeks 0-8;

  2. Mean self reported cocaine craving score [ Time Frame: 8 Weeks ]

    Cocaine craving as measured by the Visual Analog Craving Scales (VAS) during Weeks 0-8.

    Possible scores range from 0 to 100, with higher scores indicating worse craving.


  3. Measures of safety (adverse events) [ Time Frame: 8 weeks ]
    Number and severity of adverse events reported during Weeks 0-8; Number and outcomes (non-fatal and fatal) of overdose events during Weeks 0-8

  4. Mean self reported overall functioning [ Time Frame: Week 8 ]
    Self-report overall functioning as measured by the Treatment Effectiveness Assessment (TEA) at Week 8. Possible scores range from 1 to 10 for each of the 4 domains, with higher scores indicating better outcome.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262270


Contacts
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Contact: Madhukar H Trivedi, MD 214-648-0188 CURB2@UTSouthwestern.edu
Contact: Chelsea Wynn, MPH CURB2@UTSouthwestern.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35209
Contact: Melinda Clarke, MS    205-996-0211    curb2study@uabmc.edu   
Contact: Shunte Fisher, MPH    205-996-0211    curb2study@uabmc.edu   
Principal Investigator: Peter Hendricks, PhD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alison Oliveto, PhD    501-526-8441    olivetoalison@uams.edu   
Contact: Alyssah Locklear, MS    501-526-8468    alocklear@uams.edu   
Principal Investigator: Alison Oliveto, PhD         
United States, California
UCLA Vine Street Clinic Recruiting
Los Angeles, California, United States, 90038
Contact: Jasmin Tavarez    424-325-9632    uclavsc@mednet.ucla.edu   
Contact: Sandra R MacNicoll    323-461-3106    uclavsc@mednet.uc.a.edu   
Principal Investigator: Jesse Clark, MD, MSc         
Center on Substance Use and Health (CSUH) Recruiting
San Francisco, California, United States, 94102
Contact: Judy Tan, MPH    628-217-6207    judy.tan@sfdph.org   
Contact: John Walker, RN, MSN    (628) 217-6227    john.e.walker@sfdph.org   
Principal Investigator: Phillip Coffin, MD, MIA         
United States, Florida
Cove Behavioral Health Recruiting
Tampa, Florida, United States, 33605
Contact: Janet Ramos, RN    813-277-4563    janetr@covebh.org   
Contact: Stephanie Samayoa, MPA    813-894-3609    stephanies@covebh.org   
Principal Investigator: Venkat Muvva, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60608
Contact: Lily Caglianone, BS       cagliano@uic.edu   
Principal Investigator: Niranjan Karnik, MD, PhD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Madison Collins, BA    773-834-3778    mcollins4@bsd.uchicago.edu   
Contact: Jon E Grant, JD, MD, MPH    773-834-1325    jgrant4@bsd.uchicago.edu   
Principal Investigator: Jon E Grant, JD, MD, MPH         
United States, Maryland
Mountain Manor Treatment Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Kevin Wenzel, PhD    410-233-1400    kwenzel@marylandtreatment.org   
Contact: Aline Rabalais, PhD    409-767-0843    arabablais@marylandtreatment.org   
Principal Investigator: Marc Fishman, MD         
United States, Minnesota
Berman Center for Outcomes and Clinical Research at Hennepin Healthcare Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Leah Stevens    763-568-6969    lstevens@bermancenter.org   
Contact: Nate Tessum    612-873-6921    ntessum@bermancenter.org   
Principal Investigator: Gavin Bart, MD, PhD         
United States, New York
Addictions Institute of Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Ashanta Carter, MSH    212-844-5717    curb2study@mssm.edu   
Contact: Samantha Huang, BS    212-585-4671    curb2study@mssm.edu   
Principal Investigator: Keren Bachi, PhD         
United States, Texas
UTSW Medical Center, Center for Depression Research and Clinical Care Recruiting
Dallas, Texas, United States, 75247
Contact: Isabella Huddleston    817-262-9157    CURB2_109@UTSouthwestern.edu   
Contact: McKenna Dougherty    469-602-2362    CURB2_109@UTSouthwestern.edu   
Principal Investigator: Sidarth Wakhlu, MD         
University of Texas Health San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Madhukar Trivedi, MD UT Southwestern Medical Center
More Information
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Publications:
Center for Behavioral Health Statistics and Quality. 2019 National Survey on Drug Use and Health (NSDUH): CAI Specifications for Programming (English Version). Substance Abuse and Mental Health Services Administration, editor. Rockville, MD; 2018.

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Responsible Party: Madhukar H. Trivedi, MD, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05262270    
Other Study ID Numbers: STU-2021-0223
UG1DA020024 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants. The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the National Institute on Drug Abuse (NIDA) Data Share Agreement.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: This will be available five months after all sites are closed. No yet determined duration of availability.
Access Criteria: Researchers who are active users on the https://datashare.nida.nih.gov/ site. Primary data will be available to the public in the NIDA data repository on this site as well.
URL: https://datashare.nida.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
Naltrexone
Buprenorphine
Extended release injectable Naltrexone
Extended release injectable Buprenorphine
 CUD
Cocaine
Cocaine Abuse
Additional relevant MeSH terms:
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Naltrexone
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents