Evidence map›Paper›PMID 35218405›Full record

Trial reportEuropean journal of clinical pharmacology2022

Moderation of buprenorphine therapy for cocaine dependence efficacy by variation of the Prodynorphin gene.

David A Nielsen, Robrina Walker, David P Graham, Ellen M Nielsen, Sara C Hamon, Maureen Hillhouse, Dikla Shmueli-Blumberg, William B Lawson, Kathy Shores-Wilson, Beverlyn D Settles-Reaves and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01402492 (Cocaine Use Reduction With Buprenorphine), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 53% of its field
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.

NCT01402492 phase2 / phase3completednot on this map

Cocaine Use Reduction With Buprenorphine (CURB)

TypeinterventionalSponsorUniversity of California, Los AngelesRan2011 to 2013Enrolled302ConditionsCocaine DependenceArmsBuprenorphine + Naltrexone, Placebo + Naltrexone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Review
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

15 authors at 9 institutions in 1 country.

David A NielsenThe Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 2002 Holcombe Blvd., Research 151, Building 110, Suite 227, Houston, TX, 77030, USA. nielsen@bcm.edu.ORCID http://orcid.org/0000-0002-2583-0233
Robrina WalkerUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
David P GrahamThe Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 2002 Holcombe Blvd., Research 151, Building 110, Suite 227, Houston, TX, 77030, USA.
Ellen M NielsenThe Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 2002 Holcombe Blvd., Research 151, Building 110, Suite 227, Houston, TX, 77030, USA.
Sara C HamonStatistical and Genetic Consulting LLC, Daren, CT, USA.
Maureen HillhouseIntegrated Substance Abuse Programs, UCLA, Los Angeles, CA, USA.
Dikla Shmueli-BlumbergThe Emmes Company, Rockville, MD, USA.
William B LawsonDepartment of Psychiatry and Behavioral Sciences, Howard University, Washington, D.C, USA.
Kathy Shores-WilsonUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Beverlyn D Settles-ReavesDepartment of Psychiatry and Behavioral Sciences, Howard University, Washington, D.C, USA.
John RotrosenNew York University School of Medicine, New York University, New York, NY, USA.
Madhukar H TrivediUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Andrew J SaxonCenter of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System and Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System and Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, WA, USA.
Walter LingIntegrated Substance Abuse Programs, UCLA, Los Angeles, CA, USA.
Thomas R KostenThe Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 2002 Holcombe Blvd., Research 151, Building 110, Suite 227, Houston, TX, 77030, USA.
The University of Texas Southwestern Medical Center · USBaylor College of Medicine · USHoward University · USMichael E. DeBakey VA Medical Center · USOASIS Clinic · USEmmes (United States) · USNew York University · USStatistical Research (United States) · USVA Puget Sound Health Care System · US

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
Project-004UG1DA020024 · NIDA · UT SOUTHWESTERN MEDICAL CENTER · PI Steven J Shoptaw, MADHUKAR H. TRIVEDI · 2015 to 2026
$71.6M
The National Drug Abuse Treatment Clinical Trials NetworkU10DA013045 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LING, WALTER NMN · 1999 to 2015
$52.6M
CU PARTNERS: NY/LONG ISLAND REGIONAL NODEU10DA013035 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI NUNES, EDWARD V., ROTROSEN, JOHN P · 2001 to 2015
$47.6M
Western States Node of the National Drug Abuse Treatment Clinical Trials NetworkU10DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MCCARTY, DENNIS, SORENSEN, JAMES L · 2002 to 2015
$25.2M
Western States Node of the National Drug Abuse Treatment Clinical Trials Network (TMS for CUD) UG1DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Keith N. Humphreys, Philip Todd Korthuis · 2015 to 2026
$24.6M
Concept ProjectU10DA020024 · NIDA · UT SOUTHWESTERN MEDICAL CENTER · PI TRIVEDI, MADHUKAR H. · 2005 to 2015
$22.6M
NIDA CLINICAL TRIALS NETWORK - NYC EAST SIDE NODEU10DA013046 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ROTROSEN, JOHN P · 2000 to 2009
$20.2M
Tiagabine and Disulfiram for Cocaine DependenceP50DA018197 · NIDA · YALE UNIVERSITY · PI KOSTEN, THOMAS RICHARD · 2004 to 2013
$12.6M
Innovative Multidisciplinary Education: The Statistical Genetics of AddictionR25DA026120 · NIDA · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI CHANG, SHINE, SHETE, SANJAY · 2010 to 2014
$1.5M
NIDA NIH HHS DA013035NIDA NIH HHS DA013045NIDA NIH HHS DA013046NIDA NIH HHS DA015815NIDA NIH HHS DA018197NIDA NIH HHS DA020024NIH HHS DA026120
6 · The paper itself

Abstract

purposeThe aim of this secondary analysis was to identify prodynorphin (PDYN) genetic markers moderating the therapeutic response to treatment of cocaine dependence with buprenorphine/naloxone (Suboxone®; BUP).

methodsCocaine-dependent participants (N = 302) were randomly assigned to a platform of injectable, extended-release naltrexone (XR-NTX) and one of three daily medication arms: 4 mg BUP (BUP4), 16 mg BUP (BUP16), or placebo (PLB) for 8 weeks (Parent Trial Registration: Protocol ID: NIDA-CTN-0048, Clinical Trials.gov ID: NCT01402492). DNA was obtained from 277 participants. Treatment response was determined from weeks 3 to 7 over each 1-week period by the number of cocaine-positive urines per total possible urines.

resultsIn the cross-ancestry group, the PLB group had more cocaine-positive urines than the BUP16 group (P = 0.0021). The interactions of genetic variant × treatment were observed in the rs1022563 A-allele carrier group where the BUP16 group (N = 35) had fewer cocaine-positive urines (P = 0.0006) than did the PLB group (N = 26) and in the rs1997794 A-allele carrier group where the BUP16 group (N = 49) had fewer cocaine-positive urines (P = 0.0003) than did the PLB group (N = 58). No difference was observed in the rs1022563 GG or rs1997794 GG genotype groups between the BUP16 and PLB groups. In the African American-ancestry subgroup, only the rs1022563 A-allele carrier group was associated with treatment response.

conclusionThese results suggest that PDYN variants may identify patients who are best suited to treatment with XR-NTX plus buprenorphine for cocaine use disorder pharmacotherapy.

Indexed as

BuprenorphineCocaineCocaine-Related DisordersOpioid-Related DisordersBuprenorphine, Naloxone Drug CombinationDelayed-Action PreparationsEnkephalinsHumansInjections, IntramuscularNaltrexoneNarcotic AntagonistsProtein PrecursorsBuprenorphineBuprenorphine, Naloxone Drug CombinationCocaineDelayed-Action PreparationsEnkephalinsNaltrexoneNarcotic AntagonistspreproenkephalinProtein PrecursorsBuprenorphineCocaineGenePolymorphismProdynorphin

Identifiers

PMID35218405
OpenAlexW4214662056

What OpenQuestion holds

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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.