Evidence map›Paper›PMID 33249498›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2021

Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial.

Nicolle M Krebs, Junjia Zhu, Emily Wasserman, Robin Kuprewicz, Diane J Martinez, Susan Veldheer, Craig Livelsberger, Jennifer Modesto, Lisa Reinhart, Neil Trushin and 8 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. 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
    Article
  7. Continuous Nicotine Monitors for Personal Nicotine Pharmacokinetics: A Receptor-Aware Research Agenda.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Review
  8. Article
  9. Article
  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. Review
  19. Article
  20. Reducing the Nicotine Content of Cigarettes: Effects in Smokers With Mental Health Conditions and Socioeconomic Disadvantages.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    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

18 authors.

Nicolle M KrebsDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.ORCID 0000-0002-5824-4572
Junjia ZhuDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Emily WassermanDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Robin KuprewiczDepartment of Psychiatry, Georgetown University, Washington, DC.
Diane J MartinezPublic Health Division, Arlington County Department of Human Services, Arlington, VA.
Susan VeldheerDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Craig LivelsbergerDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Jennifer ModestoDepartment of Biochemistry and Molecular Biology, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Lisa ReinhartDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Neil TrushinDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Samantha M ReillyDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Jason LiaoDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Alyse FazziDepartment of Pharmacy, Investigational Drug Service Pharmacy, Penn State Health, Hershey, PA.
Rebecca BascomDepartment of Medicine, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
John P RichieDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Jonathan FouldsDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Kimberly HornDepartment of Population Health Sciences, Virginia Tech Carilion Research Institute, Roanoke, VA.
Joshua E MuscatDepartment of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.

Funding

Penn State Clinical and Translational Science InstituteUL1TR002014 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KRASCHNEWSKI, JENNIFER L. · 2016 to 2025
$33.7M
Research Training and Educational Component (Component I) p370-385P50DA036107 · NIDA · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI FOULDS, JONATHAN, MUSCAT, JOSHUA E · 2013 to 2018
$19.5M
Penn State Clinical and Translational Science InstituteUL1TR000127 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI SINOWAY, LAWRENCE I · 2012 to 2015
$17.1M
NCATS NIH HHS UL1 TR000127NCATS NIH HHS UL1 TR002014NIDA NIH HHS P50 DA036107
6 · The paper itself

Abstract

introductionThe Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC).

methodsA 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation.

resultsThe RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%).

conclusionsThis study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.

Indexed as

Smoking CessationTobacco ProductsTobacco Use DisorderAdultFemaleHumansMaleNicotineSmokersSocial ClassNicotine

Identifiers

PMID33249498
PMCPMC8150128

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.