Evidence map›Paper›PMID 19023835›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2008

Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology.

Jennifer N Gray, Alison B Breland, Michael Weaver, Thomas Eissenberg

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00932295 (Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 20% 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.

NCT00932295 phase1 / phase2completednot on this mapstarted 2009, after this paper: background citation

Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2009 to 2009Enrolled32ConditionsSmokingArmsOB, Sham smoking, CROWN SEVEN, NJOY
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Interventions to reduce harm from continued tobacco use.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Measures for assessing subjective effects of potential reduced-exposure products.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2009
    Pooled it
  3. Trial
  4. Trial
  5. Acute effects of snus in never-tobacco users: a pilot study.The American journal of drug and alcohol abuse · 2018
    Trial
  6. Effect of oral snus and medicinal nicotine in smokers on toxicant exposure and withdrawal symptoms: a feasibility study.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2011
    Trial
  7. Evaluating oral noncombustible potential-reduced exposure products for smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2010
    Trial
  8. Article
  9. Article
  10. Nicotine Absorption from Smokeless Tobacco Modified to Adjust pH.Journal of addiction research & therapy · 2014
    Article
  11. Subjective responses to oral tobacco products: scale validation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2013
    Article
  12. Dependence on tobacco and nicotine products: a case for product-specific assessment.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012
    Article
  13. Article
  14. A clinical laboratory model for evaluating the acute effects of electronic "cigarettes": nicotine delivery profile and cardiovascular and subjective effects.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2010
    Article
  15. Abuse liability assessment of tobacco products including potential reduced exposure products.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2009
    Review
  16. Clinical trials methods for evaluation of potential reduced exposure products.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2009
    Review
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

4 authors at 1 institution in 1 country.

Jennifer N GrayVirginia Commonwealth University, Richmond, VA 23298-0205, USA.
Alison B Breland
Michael Weaver
Thomas Eissenberg
Virginia Commonwealth University · US

Funding

Clinical models for evaluating PREPs for tobacco usersR01CA103827 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI EISSENBERG, THOMAS EVAN · 2004 to 2008
$2.1M
NCI NIH HHS CA103827NCI NIH HHS R01 CA103827
6 · The paper itself

Abstract

Several potential reduced exposure products (PREPs) for smokeless tobacco (SLT) users are marketed in the United States, though their effects are largely unknown. These products include some that are low in tobacco-specific nitrosamines (TSNs), like Stonewall, a pressed tobacco tablet, and General snus, a moist snuff product produced in Sweden. Methodology assessing the toxicant exposure and effects of cigarette-like PREPs for smokers has been developed, and might be modified for use in evaluating PREPs for SLT users. This report describes two studies examining the toxicant exposure and effects of two PREPs for SLT users. Study 1 (n = 13) consisted of four 4.5-hr laboratory sessions where SLT products (own brand, Stonewall, General snus, and tobacco-free placebo) were used for four 30-min episodes and nicotine exposure and tobacco/nicotine abstinence symptoms were measured. Study 2 (n = 19) consisted of four 5-day ad libitum use periods when participants used own brand, Stonewall, General snus, or no SLT and urinary levels of metabolites of nicotine (cotinine) and the TSN 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNAL) and abstinence symptoms were measured. Compared with own brand, Stonewall was associated with lower levels of cotinine and NNAL, while General snus was associated with similar levels of cotinine and lower levels of NNAL. Abstinence symptoms generally did not differ across tobacco conditions. These results show that clinical laboratory methods can be used to evaluate the toxicant exposure and abstinence symptom suppression associated with PREPs for SLT users.

Indexed as

Environmental MonitoringHarm ReductionAdultBiomarkersCarbon MonoxideCarcinogensCotinineFemaleHumansInhalation ExposureMaleMiddle AgedNicotineNitrosaminesTobacco, SmokelessTobacco Use Cessation4-(N-methyl-N-nitrosamino)-1-(3-pyridyl)-1-butanoneBiomarkersCarbon MonoxideCarcinogensCotinineNicotineNitrosamines

Identifiers

PMID19023835
PMCPMC3212707
OpenAlexW2057685298

What OpenQuestion holds

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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.