Evidence map›Paper›PMID 31867650›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2019

Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.

Jennifer W Tidey, Suzanne M Colby, Rachel L Denlinger-Apte, Christine Goodwin, Patricia A Cioe, Rachel N Cassidy, Robert M Swift, Bruce R Lindgren, Nathan Rubin, Sharon E Murphy and 3 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
4.2field-weighted citation impact, top 5% 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.

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

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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
  4. Trial
  5. Trial
  6. The Impact of Reducing Nicotine Content on Adolescent Cigarette Smoking and Nicotine Exposure: Results From a Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Predicting Non-Adherence With Very Low Nicotine Content Cigarettes Among Adults With Serious Mental Illness Who Smoke.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Trial
  11. Trial
  12. Trial
  13. An Evaluation of Potential Unintended Consequences of a Nicotine Product Standard: A Focus on Drinking History and Outcomes.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021
    Trial
  14. Trial
  15. Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020
    Trial
  16. 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
  17. Article
  18. Observational
  19. Article
  20. 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

13 authors at 3 institutions in 1 country.

Jennifer W TideyCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Suzanne M ColbyCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Rachel L Denlinger-ApteCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Christine GoodwinCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Patricia A CioeCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Rachel N CassidyCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Robert M SwiftCenter for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.
Bruce R LindgrenMasonic Cancer Center, University of Minnesota, Minneapolis, MN.
Nathan RubinMasonic Cancer Center, University of Minnesota, Minneapolis, MN.
Sharon E MurphyMasonic Cancer Center, University of Minnesota, Minneapolis, MN.
Stephen S HechtMasonic Cancer Center, University of Minnesota, Minneapolis, MN.
Dorothy K HatsukamiMasonic Cancer Center, University of Minnesota, Minneapolis, MN.
Eric C DonnyDepartment of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.
Brown University · USUniversity of Minnesota · USWake Forest University · US

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
University of Vermont Tobacco Center of Regulatory ScienceU54DA036114 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2018 to 2022
$19.4M
Substance Abuse Intervention/Outcome Research TrainingT32DA016184 · NIDA · BROWN UNIVERSITY · PI Damaris J. Rohsenow, JENNIFER W. TIDEY · 2003 to 2026
$6.1M
Evaluation of Very Low Nicotine Content Cigarettes in Adolescent SmokersK01CA189300 · NCI · BROWN UNIVERSITY · PI CASSIDY, RACHEL N · 2014 to 2018
$897k
NCATS NIH HHS UL1 TR002494NCI NIH HHS K01 CA189300NCI NIH HHS P30 CA077598NIDA NIH HHS T32 DA016184NIDA NIH HHS U54 DA031659NIDA NIH HHS U54 DA036114
6 · The paper itself

Abstract

introductionThe US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.

methodsThis trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.

resultsAt week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.

conclusionsThese results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine. IMPLICATIONS: Results from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.

Indexed as

Mental DisordersNicotineSmokingSmoking CessationAdultFemaleHumansMaleMiddle AgedTobacco ProductsNicotine

Identifiers

PMID31867650
PMCPMC6939771
OpenAlexW2997410539

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.