Evidence map›Paper›PMID 40360074›Full record

ArticleContemporary clinical trials2025

Randomized, placebo-controlled trial of injectable extended-release naltrexone and injectable extended-release buprenorphine for cocaine use disorder (CURB-2): Study rationale and design.

Madhukar H Trivedi, Mariah M Kalmin, Thomas Carmody, Edward M Chongsi, Udi E Ghitza, Manish K Jha, Taryn L Mayes, Angela Casey-Willingham, Sangita Sethuram, Elise N Marino and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05262270 (Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05262270 phase2completednot on this map

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

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2023 to 2025Enrolled427ConditionsCocaine Use DisorderArmsExtended-Release Naltrexone, Extended Release Buprenorphine, Placebo (PLB) Injectable matched to XR-NTX, Placebo (PLB) Injectable matched to XR-BUP
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Madhukar H TrivediCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA. Electronic address: Madhukar.Trivedi@utsouthwestern.edu.
Mariah M KalminDepartment of Family Medicine, University of California, Los Angeles, 1800 Wilshire Blvd., Suite 1800, CA 90024, USA.
Thomas CarmodyCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA; Department of Health Data Science and Biostatistics, Peter O'Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Edward M ChongsiThe Emmes Company, LLC, 401 N Washington St #700, Rockville, MD 20850, USA.
Udi E GhitzaCenter for the Clinical Trials Network (CCTN), The National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Rockville, MD, USA.
Manish K JhaCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Taryn L MayesCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Angela Casey-WillinghamCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Sangita SethuramCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Elise N MarinoBe Well Institute on Substance Use and Related Disorders, University of Texas Health Science Center at San Antonio, 5109 Medical Drive, San Antonio, TX 78229, USA; Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, 5109 Medical Drive, San Antonio, TX 78229, USA.
Maria MonastirskyCenter for Depression Research and Clinical Care, Peter O'Donnell Jr. Brain Institute and Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.
Steven J ShoptawDepartment of Psychiatry and Biobehavioral Sciences, Department of Family Medicine, University of California Los Angeles, 405 Hilgard Avenue, Los Angeles, CA 90095, USA.

Funding

Project-004UG1DA020024 · NIDA · UT SOUTHWESTERN MEDICAL CENTER · PI Steven J Shoptaw, MADHUKAR H. TRIVEDI · 2015 to 2026
$71.6M
NIDA NIH HHS UG1 DA020024
6 · The paper itself

Abstract

backgroundCocaine remains the most abused stimulant, causing considerable morbidity and mortality. Despite decades of research, there is no FDA-approved medication to treat cocaine use disorder (CUD). In individuals with cocaine and opioid dependence/abuse, extended-release injectable naltrexone (XR-NTX) and sublingual buprenorphine (BUP; 16 mg with naloxone; Suboxone) reduced cocaine use compared to placebo and XR-NTX in the 'Cocaine Use Reduction with Buprenorphine' (CURB; CTN-0048) study.

objectivesThe CURB-2 (CTN-0109) study aims to examine whether administering XR-NTX in combination with extended-release injectable buprenorphine (XR-BUP), thus creating a "kappa antagonist," is an effective pharmacotherapy compared to placebo for the treatment of CUD. STUDY

designCURB-2 is a fully powered, phase IIb, randomized, placebo-controlled trial. Approximately 426 participants will be randomized across 12 study sites in the United States. There will be a 1-week medication induction phase, an 8-week active medication phase, and a 4-week follow-up phase. XR-NTX (Day 1, Week 3, Week 6) will be administered before XR-BUP (Day 4, Week 4). With naltrexone blocking the mu-opioid receptors, the reinforcing effects of buprenorphine will be blocked while leaving the kappa antagonist effects. DISCUSSION: If this kappa antagonist approach demonstrates efficacy in reducing urine-verified cocaine use compared to placebo, XR-NTX and XR-BUP combination therapy would be an important tool in addressing cocaine use disorder. CLINICAL TRIALS REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT05262270.

Indexed as

BuprenorphineCocaine-Related DisordersNaltrexoneNarcotic AntagonistsAdultClinical Trials, Phase II as TopicDelayed-Action PreparationsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInjectionsMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicBuprenorphineDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsBuprenorphineClinical trialCocaine use disorderNaltrexoneTreatment

Identifiers

PMID40360074
PMCPMC12798897

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.