Evidence map›Paper›PMID 38911348›Full record

ArticleLancet regional health. Americas2024

Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.

Dorothy K Hatsukami, Joni A Jensen, Dana Mowls Carroll, Xianghua Luo, Lori G Strayer, Qing Cao, Stephen S Hecht, Sharon E Murphy, Steven G Carmella, Rachel L Denlinger-Apte and 6 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Lancet regional health. Americas, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03272685 (Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 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.

NCT03272685 phase3completednot on this map

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"

TypeinterventionalSponsorUniversity of MinnesotaRan2018 to 2023Enrolled799ConditionsTobacco Smoking, Nicotine DependenceArmsVery Low Nicotine Content Cigarettes, Normal Nicotine Content Cigarettes
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Examining Spontaneous Cognitive and Emotional Reactions to Messages About Very Low Nicotine Cigarettes (VLNCs).Health education & behavior : the official publication of the Society for Public Health Education · 2026
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  17. E-Liquid Flavor Availability Significantly Affects Cigarette and E-Liquid Purchasing in an Experimental Marketplace Simulating a Low Nicotine Product Standard.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Dorothy K HatsukamiDepartment of Psychiatry and Behavioral Sciences, Medical School, University of Minnesota, Minneapolis, MN, USA.
Joni A JensenMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Dana Mowls CarrollDivision of Environmental Health Sciences, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Xianghua LuoMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Lori G StrayerMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Qing CaoMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Stephen S HechtMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Sharon E MurphyMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Steven G CarmellaMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Rachel L Denlinger-ApteDepartment of Social Sciences and Health Policy, School of Medicine, Wake Forest University, Winston Salem, NC, USA.
Suzanne ColbyCenter for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI, USA.
Andrew A StrasserDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
F Joseph McClernonDepartment of Psychiatry and Behavioral Sciences, School of Medicine, Duke University, Durham, NC, USA.
Jennifer TideyCenter for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI, USA.
Neal L BenowitzDepartment of Medicine, School of Medicine, University of California, San Francisco, CA, USA.
Eric C DonnyDepartment of Physiology and Pharmacology, School of Medicine, Wake Forest University, Winston Salem, NC, USA.

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)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
Laying the Foundation for Personalized Smoking Cessation Treatment in the American Indian PopulationK01MD014795 · NIMHD · UNIVERSITY OF MINNESOTA · PI CARROLL, DANA MOWLS · 2020 to 2024
$684k
NCATS NIH HHS UL1 TR002494NCI NIH HHS P30 CA077598NIDA NIH HHS U54 DA031659NIMHD NIH HHS K01 MD014795
6 · The paper itself

Abstract

Background: Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. Methods: In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). Findings: Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20-73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, -6.21 [95% CI, -7.66 to -4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001). Interpretation: A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. Funding: U.S. NIH/FDA U54DA03165.

Indexed as

CigarettesElectronic cigarettesNicotineNicotine delivery systemsReduced nicotine cigarettesSmoking cessationTobaccoTobacco controlTobacco policyTobacco product regulations

Identifiers

PMID38911348
PMCPMC11190722

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.