Evidence map›Paper›PMID 25991608›Full record

Trial reportTobacco control2016

Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching.

Dorothy K Hatsukami, Herbert Severson, Amanda Anderson, Rachael Isaksson Vogel, Joni Jensen, Berry Broadbent, Sharon E Murphy, Steven Carmella, Stephen S Hecht

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Tobacco control, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00710034 (Oral Tobacco as a Harm Reduction Product), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

NCT00710034 phase2completednot on this map

Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking

TypeinterventionalSponsorUniversity of MinnesotaRan2010 to 2014Enrolled391ConditionsTobacco Use DisorderArmsOral tobacco, Nicotine Gum
3 · Its place in the literature

Who cites it

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

  1. Interventions to reduce harm from continued tobacco use.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Effects of a Reduced Risk Claim on Adolescents' Smokeless Tobacco Perceptions and Willingness to Use.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2023
    Trial
  3. Trial
  4. A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2017
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Perceived Health Risks of Snus and Medicinal Nicotine Products.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. 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
  15. Article
  16. Article
  17. Review
  18. A Twin Study of Cigarette and Snus Initiation and Quantity of Use in Norwegian Adult Twins.Twin research and human genetics : the official journal of the International Society for Twin Studies · 2019
    Article
  19. Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2018
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Dorothy K HatsukamiMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
Herbert SeversonOregon Research Institute, Eugene, Oregon, USA.
Amanda AndersonDepartment of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
Rachael Isaksson VogelMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
Joni JensenDepartment of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
Berry BroadbentOregon Research Institute, Eugene, Oregon, USA.
Sharon E MurphyMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
Steven CarmellaMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
Stephen S HechtMasonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
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 Toronto Coordinating Genetics Core & Clinical Trial SiteU01DA020830 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI LERMAN, CARYN, TYNDALE, RACHEL FYNVOLA · 2005 to 2014
$22.4M
Evaluation of Oral Tobacco as a Harm Reduction Method for SmokersR01CA135884 · NCI · UNIVERSITY OF MINNESOTA · PI HATSUKAMI, DOROTHY K · 2008 to 2013
$2.7M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1TR000114NCI NIH HHS P30 CA077598NCI NIH HHS R01 CA135884NIDA NIH HHS U01 DA020830
6 · The paper itself

Abstract

backgroundAn essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure. STUDY

designCigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N'-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels.

resultsOf the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO<6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus.

conclusionsSnus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum. TRIAL REGISTRATION NUMBER: NCT: 00710034.

Indexed as

Smoking PreventionTobacco, SmokelessTobacco Use Cessation DevicesAdministration, OralAdultBiomarkersChewing GumConsumer BehaviorCotinineFemaleGlucuronidesHumansMaleMiddle AgedMinnesotaNicotine4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-olBiomarkersChewing GumCotinineGlucuronidesNicotineNicotinic AgonistsNitrosaminesN'-nitrosonornicotinePyridinesCarcinogensHarm ReductionNon-cigarette tobacco products

Identifiers

PMID25991608
PMCPMC4785094

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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.