Evidence map›Paper›PMID 34255068›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2022

Effects of Reduced Nicotine Content Cigarettes on Fractional Exhaled Nitric Oxide and Self-Reported Respiratory Health Outcomes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage.

Anthony C Oliver, Michael DeSarno, Charles G Irvin, David Kaminsky, Jennifer W Tidey, Stacey C Sigmon, Sarah H Heil, Diann E Gaalema, Dustin Lee, Janice Y Bunn and 4 more

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

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2022. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

NCT02232737 phase1 / phase2completednot on this map

Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

TypeinterventionalSponsorBrown UniversityRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
NCT02250534 phase1 / phase2completednot on this map

Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

TypeinterventionalSponsorUniversity of VermontRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
NCT02250664 phase1 / phase2completednot on this map

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers

TypeinterventionalSponsorUniversity of VermontRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

14 authors at 3 institutions in 1 country.

Anthony C OliverVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.ORCID 0000-0002-0510-148X
Michael DeSarnoVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Charles G IrvinVermont Lung Center, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
David KaminskyVermont Lung Center, Larner College of Medicine, University of Vermont, Burlington, VT, USA.ORCID 0000-0002-6515-8023
Jennifer W TideyCenter for Alcohol and Addiction Studies, Brown University, Providence, RI, USA.
Stacey C SigmonVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Sarah H HeilVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Diann E GaalemaVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Dustin LeeBehavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Janice Y BunnVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Danielle R DavisVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.ORCID 0000-0002-9436-9575
Joanna M StreckVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.ORCID 0000-0002-7842-9080
Thomas GallagherVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Stephen T HigginsVermont Center on Behavior and Health, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
University of Vermont · USBrown University · USJohns Hopkins University · US

Funding

Vermont Center on Behavior and HealthP20GM103644 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI THRAILKILL, ERIC ALLEN · 2013 to 2022
$21.3M
University of Vermont Tobacco Center of Regulatory ScienceU54DA036114 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2018 to 2022
$19.4M
Career Development Program in Substance Use and Addiction MedicineK12DA043490 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI A EDEN EVINS, NANCY A RIGOTTI · 2017 to 2026
$4.7M
NIDA NIH HHS K12 DA043490NIDA NIH HHS U54 DA036114NIGMS NIH HHS P20 GM103644
6 · The paper itself

Abstract

introductionThis study examined whether exposure to reduced-nicotine-content cigarettes (RNCCs) for 12 weeks alters respiratory health using Fractional Exhaled Nitric Oxide (FeNO), a validated biomarker of respiratory epithelial health, and the Respiratory Health Questionnaire (RHQ), a subject-rated questionnaire on respiratory symptoms. Participants were 747 adult daily smokers enrolled in three double-blind, randomized clinical trials evaluating effects of cigarette nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco) in people with affective disorders, opioid use disorder (OUD), or socioeconomic disadvantage. AIMS AND

methodsFeNO levels and RHQ ratings were collected at baseline and Weeks 6 and 12 following randomization. Multiple regression was used to assess associations of FeNO and RHQ with smoking characteristics. Mixed-model repeated-measures ANOVA was used to evaluate the effects of nicotine content on FeNO and RHQ outcomes over the 12-week study period.

resultsFeNO levels but not RHQ ratings varied inversely with smoking characteristics at baseline (Ps < 0.0001) in smokers with affective disorders and socioeconomic disadvantage but less so in those with OUD. Participants with affective disorders and socioeconomic disadvantage, but not those with OUD, who were assigned to RNCCs had higher FeNO levels at Week 12 than those assigned to the 15.8 mg/g dose [F(2,423) = 4.51, p = .01, Cohen's d = 0.21]. No significant dose-related changes in RHQ scores were identified.

conclusionsUse of RNCCs across a 12-week period attenuates smoking-related reductions in FeNO levels in smokers with affective disorders and socioeconomic disadvantage although not those with OUD. FeNO changes were not accompanied by changes in respiratory-health ratings.

trial registrationInclusion and exclusion criteria for the sample and experimental manipulation of the nicotine content of assigned cigarettes are registered: NCT02232737, NCT02250664, NCT02250534. The FeNO measure reported in this manuscript is an exploratory outcome that was not registered. IMPLICATIONS: Should a reduced nicotine content standard be implemented; these results suggest that reduced nicotine content in cigarettes will not exacerbate and instead may attenuate smoking-related decreases in FeNO. This is significant as NO is an important component in maintaining a healthy respiratory system and necessary to defend against infection. Furthermore, the results of the current study demonstrate that the adoption of the reduced nicotine content standard may result in beneficial impacts on respiratory epithelial health among vulnerable populations that are disproportionally affected by the adverse health outcomes precipitated by combustible tobacco use.

Indexed as

Smoking CessationTobacco ProductsAdultFractional Exhaled Nitric Oxide TestingHumansNicotineOutcome Assessment, Health CareRespiratory SystemSelf ReportSmokersSocioeconomic FactorsNicotine

Identifiers

PMID34255068
PMCPMC8826384
OpenAlexW3179303091

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.