Evidence map›Paper›PMID 31502736›Full record

Trial reportAddiction (Abingdon, England)2020

Impact of early nausea on varenicline adherence and smoking cessation.

Annie R Peng, Walter Swardfager, Neal L Benowitz, Jasjit S Ahluwalia, Caryn Lerman, Nicole L Nollen, Rachel F Tyndale

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 26% 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.

NCT01314001 phase3completednot on this map

Pharmacogenetics of Nicotine Addiction Treatment (PNAT)

TypeinterventionalSponsorUniversity of PennsylvaniaRan2010 to 2014Enrolled1,246ConditionsNicotine AddictionArmsVarenicline, Placebo, Transdermal Nicotine
NCT01836276 phase4completednot on this map

Understanding Disparities in Quitting in African American and White Smokers

TypeinterventionalSponsorNikki Nollen, PhD, MARan2013 to 2017Enrolled449ConditionsSmoking CessationArmsVarenicline
NCT05997901 nacompletednot on this mapstarted 2024, after this paper: background citation

Helping People Adhere to Their Varenicline Treatment by Co-creating a Conversational Agent: A Feasibility Study

TypeinterventionalSponsorCentre for Addiction and Mental HealthRan2024 to 2025Enrolled40ConditionsMedication Adherence, Smoking CessationArmsVarenicline healthbot
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Stability of Varenicline Concentration in Saliva Over 21 Days at Three Storage Temperatures.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Article
  12. Article
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

7 authors at 7 institutions in 2 countries.

Annie R PengDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
Walter SwardfagerDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
Neal L BenowitzDepartment of Medicine, and Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA, USA.ORCID 0000-0003-2041-8124
Jasjit S AhluwaliaDepartment of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.
Caryn LermanNorris Comprehensive Cancer Center and Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Nicole L NollenDepartment of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.ORCID 0000-0002-0943-0061
Rachel F TyndaleDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-1297-2053
Brown University · USCentre for Addiction and Mental Health · CASunnybrook Health Science Centre · CAUniversity of California, San Francisco · USUniversity of Kansas · USUniversity of Southern California · USUniversity of Toronto · CA

Funding

University of Toronto Coordinating Genetics Core & Clinical Trial SiteU01DA020830 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI TYNDALE, RACHEL FYNVOLA · 2005 to 2014
$22.4M
Neuroscience-based Interventions for Cancer Risk Behavior ChangeR35CA197461 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LERMAN, CARYN · 2015 to 2021
$6.0M
Understanding Disparities in Quitting in African American and White SmokersR01DA031815 · NIDA · UNIVERSITY OF KANSAS MEDICAL CENTER · PI NOLLEN, NICOLE L · 2012 to 2016
$3.2M
Centre for Addiction and Mental Health (CAMH) FoundationCIHR FDN-154294CIHR PCG-154865CIHR PJT-153286NCI NIH HHS R35 CA197461NIDA NIH HHS R01 DA031815NIDA NIH HHS U01 DA020830
6 · The paper itself

Abstract

BACKGROUND AND

aimsVarenicline effectiveness may be related to the level of adherence, which might be reduced by adverse effects such as nausea. The aim of the study was to test a possible effect of nausea on smoking cessation outcomes mediated by adherence.

designMediation path analysis.

settingMultiple sites within Canada and the United States.

participantsTreatment-seeking smokers receiving varenicline from two smoking cessation clinical trials: Quit2Live (NCT01836276; n = 449) and Pharmacogenetics of Nicotine Addiction Treatment (PNAT) (NCT01314001; n = 421). MEASUREMENTS: Nausea severity was collected through self-report and adherence was biologically assessed using varenicline concentrations (Quit2Live, plasma sample at week 4; PNAT, saliva sample at week 2). In Quit2Live, the end-points were cotinine-verified abstinence at weeks 4, 12 and 26. In PNAT, the end-points were carbon monoxide-verified abstinence at weeks 2, 12 and 26.

findingsEarly nausea was not directly associated with abstinence [odds ratio (OR) ranging from 0.73-1.28; P ≥ 0.26]. However early nausea was indirectly associated with lower cessation rates at multiple timepoints (ORs ranging from 0.92-0.94; 95% CI between 0.83-0.99) in a relationship mediated by reduced varenicline adherence (assessed by plasma varenicline concentrations) in the primary trial (Quit2Live). This relationship between nausea, adherence and cessation was similar in direction but weaker in effect size (ORs ranging from 0.98-0.99; 95% CI between 0.90-1.03) in a secondary trial (PNAT), where adherence was assessed using salivary varenicline concentrations.

conclusionsThese data suggest that early nausea during varenicline treatment may be indirectly associated with lower likelihood of smoking cessation through reducing varenicline adherence. Differences in robustness between the trials may be due to the different biological matrices (plasma vs. saliva) and/or timing used to assess varenicline adherence. The results of the first study suggest that improved management of early nausea during varenicline treatment may positively impact smoking cessation success through increasing varenicline adherence.

Indexed as

Medication AdherenceNauseaSmoking CessationSmoking Cessation AgentsVareniclineAdultCanadaFemaleHumansMaleMediation AnalysisMiddle AgedUnited StatesSmoking Cessation AgentsVareniclineAdherenceadverse eventscompliancenauseasmoking cessationvarenicline

Identifiers

PMID31502736
PMCPMC6933078
OpenAlexW2973019311

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.