Evidence map›Paper›PMID 31542129›Full record

Trial reportAmerican journal of preventive medicine2019

Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine.

Tracy T Smith, Joseph S Koopmeiners, Katelyn M Tessier, Esa M Davis, Cynthia A Conklin, Rachel L Denlinger-Apte, Tonya Lane, Sharon E Murphy, Jennifer W Tidey, Dorothy K Hatsukami and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of preventive medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02301325 (Project 1, Study 2), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–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.

NCT02301325 nacompletednot on this map

Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

TypeinterventionalSponsorWake Forest University Health SciencesRan2014 to 2017Enrolled240ConditionsCigarette SmokingArmsSmoking research cigarettes with or without NRT
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Regulatory Approaches and Implementation of Minimally Addictive Combusted Products.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. The Impact of Three Alternate Nicotine-Delivery Products on Combusted Cigarette Use: A Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Trial
  7. Educating the Public on the Health Risks of Very Low Nicotine Content Cigarettes: Results From a US-Based Convenience Sample.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Trial
  8. Trial
  9. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2020
    Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Reducing Misperceptions About Very Low Nicotine Content Cigarettes: Insights From Adults Who Smoke.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Article
  17. Review
  18. Reappraising Choice in Addiction: Novel Conceptualizations and Treatments for Tobacco Use Disorder.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Article
  19. Review
  20. Calibrated dynamic borrowing using capping priors.Journal of biopharmaceutical statistics · 2021
    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

11 authors.

Tracy T SmithDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. Electronic address: smithtra@musc.edu.
Joseph S KoopmeinersDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.
Katelyn M TessierMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.
Esa M DavisDepartment of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Cynthia A ConklinDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.
Rachel L Denlinger-ApteDepartment of Behavioral and Social Sciences, Brown School of Public Health, Brown University, Providence, Rhode Island.
Tonya LaneMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.
Sharon E MurphyMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Biochemistry Molecular Biology and BioPhysics, University of Minnesota, Minneapolis, Minnesota.
Jennifer W TideyDepartment of Behavioral and Social Sciences, Brown School of Public Health, Brown University, Providence, Rhode Island.
Dorothy K HatsukamiMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota.
Eric C DonnyDepartment of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Timothy C. Hallstrom · 1998 to 2026
$100.4M
VERY LOW NICOTINE CIGARETTES IN SMOKERS WITH SCHIZOPHRENIAU54DA031659 · NIDA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HATSUKAMI, DOROTHY K · 2011 to 2022
$64.7M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Impact of e-cigarette characteristics on reinforcement and tobacco use patterns among current smokersK01DA047433 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SMITH, TRACY TAYLOR · 2019 to 2023
$988k
NCATS NIH HHS UL1 TR000114NCI NIH HHS P30 CA077598NIDA NIH HHS K01 DA047433NIDA NIH HHS U54 DA031659
6 · The paper itself

Abstract

introductionA mandated reduction in the nicotine content of cigarettes may decrease smoking, but also increase demand for other nicotine products. The present study tested the impact of smoking cigarettes with very low nicotine content and concurrent use of a transdermal nicotine patch. STUDY

designA balanced 2 × 2 factorial randomized clinical trial investigating the impact of cigarette nicotine content (double-blind, very low nicotine content versus normal nicotine content) and use of a transdermal nicotine patch (open label, patch versus no patch). SETTING/

participantsAdult daily smokers (n=240) in the Pittsburgh, PA area.

interventionParticipants were provided with research cigarettes and transdermal nicotine patches (if assigned to patch condition) for 7 weeks. Cigarettes were Spectrum brand (National Institute on Drug Abuse) and either 15.8 mg nicotine/g tobacco (normal nicotine content) or 0.4 mg nicotine/g tobacco (very low nicotine content). In the 7th week, participants were monetarily incentivized to abstain from smoking.

main outcome measuresParticipants reported daily cigarette use throughout the trial and the primary outcome was average number of cigarettes smoked per day (study + nonstudy) during Week 6. Participants were recruited from 2015 to 2017 and data were analyzed between 2017 and 2018.

resultsAssignment to very low nicotine content cigarettes and assignment to wear a nicotine patch both reduced the number of cigarettes smoked per day during Week 6 (p=0.001 and 0.04, respectively). However, assignment to the patch along with very low nicotine content cigarettes did not significantly reduce cigarette smoking compared with assignment to very low nicotine content cigarettes alone.

conclusionsA mandated reduction in the nicotine content of cigarettes is likely to reduce the number of cigarettes smoked per day, but the added benefit of concurrent transdermal nicotine is unclear. Future studies should investigate whether alternative sources of noncombusted tobacco, such as e-cigarettes, enhance the effects of very low nicotine content cigarettes on smoking.

trial registrationThis study is registered at www.clinicaltrials.gov NCT02301325.

Indexed as

Tobacco Use Cessation DevicesAdultCigarette SmokingDouble-Blind MethodFemaleHumansMaleMiddle AgedNicotineOutcome Assessment, Health CareSmoking CessationTobacco ProductsNicotine

Identifiers

PMID31542129
PMCPMC6756174

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.