Evidence map›Paper›PMID 31140663›Full record

Trial reportAddiction (Abingdon, England)2019

Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects.

Dorothy K Hatsukami, Xianghua Luo, Alisa K Heskin, Mei Kuen Tang, Steven G Carmella, Joni Jensen, Jason D Robinson, Ryan Vandrey, David J Drobes, Andrew A Strasser and 8 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. 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
  2. Article
  3. Article
  4. Article
  5. 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.

Dorothy K HatsukamiMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-1108-2609
Xianghua LuoMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0001-7501-6582
Alisa K HeskinMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Mei Kuen TangMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-4491-8038
Steven G CarmellaMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Joni JensenMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Jason D RobinsonDepartment of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ryan VandreyDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.
David J DrobesMoffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.
Andrew A StrasserDepartment of Psychiatry, Philadelphia, University of Pennsylvania, PA, USA.
Mustafa al'AbsiBehavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, MN, USA.
Scott LeischowMayo Clinic, Health Sciences Research, Scottsdale, AZ, USA.
Paul M CinciripiniDepartment of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-2877-9928
Joseph KoopmeinersDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Joshua IkuemonisanMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Neal L BenowitzDepartment of Medicine, University of California, San Francisco, CA, USA.ORCID 0000-0003-2041-8124
Eric C DonnyDepartment of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Stephen S HechtMasonic Cancer Center, University of Minnesota, Minneapolis, MN, 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)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
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
Stress, Appetite, and Smoking RelapseR01DA027232 · NIDA · UNIVERSITY OF MINNESOTA · PI AL'ABSI, MUSTAFA, LEE, DUSTIN CLARK · 2010 to 2025
$4.6M
Stress Response and Opioid Dysfunction in Nicotine DependenceR01DA016351 · NIDA · UNIVERSITY OF MINNESOTA DULUTH · PI AL'ABSI, MUSTAFA · 2003 to 2023
$4.5M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR002494NCI NIH HHS P30 CA077598NIDA NIH HHS R01 DA016351NIDA NIH HHS R01 DA027232NIDA NIH HHS U54 DA031659
6 · The paper itself

Abstract

aimA previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects.

designThree-arm, randomized controlled trial.

settingTen United States academic institutional sites.

participantsDaily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity.

interventions(1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). MEASUREMENTS: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters.

findingsNo consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference =  -0.11; 95% confidence interval (CI) = -0.18, -0.04, P = 0.004] and normal nicotine control groups (mean difference = - 0.15, 95% CI = -0.23, -0.06, P = 0.001).

conclusionIt remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

Indexed as

Tobacco ProductsAdultBayes TheoremBiomarkersCigarette SmokingC-Reactive ProteinDinoprostDinoprostoneErythrocyte CountErythrocyte IndicesFemaleHumansInflammationLeukocyte CountMaleMiddle Aged15-keto-13,14-dihydroprostaglandin E28-epi-prostaglandin F2alphaBiomarkersC-Reactive ProteinDinoprostDinoprostoneNicotineNicotinic AgonistsBiomarkers of biological effectshematological parametersimmediate versus gradual nicotine reductioninflammationoxidative stressreduced nicotine content cigarettes

Identifiers

PMID31140663
PMCPMC6732016

What OpenQuestion holds

Textmetadata
LicenceTDM
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.