Evidence map›Paper›PMID 26422724›Full record

Trial reportThe New England journal of medicine2015

Randomized Trial of Reduced-Nicotine Standards for Cigarettes.

Eric C Donny, Rachel L Denlinger, Jennifer W Tidey, Joseph S Koopmeiners, Neal L Benowitz, Ryan G Vandrey, Mustafa al'Absi, Steven G Carmella, Paul M Cinciripini, Sarah S Dermody and 13 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01681875 (Project 1, Study 1), which is not on this map. Cited by 288 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
288citing papers in PubMed, 13 pooled it
23.8field-weighted citation impact, top 1% 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.

NCT01681875 nacompletednot on this map

Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

TypeinterventionalSponsorWake Forest University Health SciencesRan2013 to 2014Enrolled839ConditionsTobacco DependenceArmsvery low nicotine content cigarettes
3 · Its place in the literature

Who cites it

288 citing papers in PubMed, 13 syntheses or guidelines pooled it, 403 citations in OpenAlex.

  1. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Pooled it
  3. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
  5. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2024
    Pooled it
  6. Pooled it
  7. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2022
    Pooled it
  8. Pooled it
  9. 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
  10. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  11. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  12. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2020
    Pooled it
  13. Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Pooled it
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228 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 12 institutions in 1 country.

Eric C DonnyFrom the Departments of Psychology (E.C.D., R.L.D., S.S.D., T.L.) and Medicine (H.T.), University of Pittsburgh, Pittsburgh; the Center for Alcohol and Addiction Studies, Brown University, Providence, RI (J.W.T.); the Division of Biostatistics, School of Public Health (J.S.K., C.T.L.), the Departments of Biochemistry, Molecular Biology, and Biophysics (S.E.M.) and Psychiatry (D.K.H.) and the Masonic Cancer Center (J.S.K., S.G.C., S.S.H., J.J., C.T.L., S.E.M., D.K.H.), University of Minnesota, Minneapolis, and the University of Minnesota Medical School, Duluth (M.A.) - all in Minnesota; the Departments of Medicine and Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco (N.L.B.); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore (R.G.V., M.L.S.), and National Institute on Drug Abuse, Bethesda (I.D.M.) - both in Maryland; the Department of Behavioral Science, University of Texas M.D. Anderson Cancer Center, Houston (P.M.C., J.D.R.); the Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL (D.J.D.); the Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC (F.J.M.); and the Department of Psychiatry, Perelman School of Medicine, and Abramson Cancer Center, University of Pennsylvania, Philadelphia (A.A.S.).
Rachel L Denlinger
Jennifer W Tidey
Joseph S Koopmeiners
Neal L Benowitz
Ryan G Vandrey
Mustafa al'Absi
Steven G Carmella
Paul M Cinciripini
Sarah S Dermody
David J Drobes
Stephen S Hecht
Joni Jensen
Tonya Lane
Chap T Le
F Joseph McClernon
Ivan D Montoya
Sharon E Murphy
Jason D Robinson
Maxine L Stitzer
Andrew A Strasser
Hilary Tindle
Dorothy K Hatsukami
University of Minnesota · USUniversity of Pittsburgh · USJohns Hopkins Medicine · USThe University of Texas MD Anderson Cancer Center · USBrown University · USDuke University · USJohns Hopkins University · USMoffitt Cancer Center · USNational Institute on Drug Abuse · USUniversity of California, San Francisco · USUniversity of Minnesota, Duluth · USUniversity of Pennsylvania · US

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
VERY LOW NICOTINE CIGARETTES IN SMOKERS WITH SCHIZOPHRENIAU54DA031659 · NIDA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI LE, CHAP T. · 2011 to 2022
$64.7M
Translational Research Support CoreP30ES013508 · NIEHS · UNIVERSITY OF PENNSYLVANIA · PI Trevor M Penning · 2006 to 2026
$35.3M
NCI NIH HHS P30 CA077598NIDA NIH HHS U54 DA031659NIEHS NIH HHS P30 ES013508
6 · The paper itself

Abstract

backgroundThe Food and Drug Administration can set standards that reduce the nicotine content of cigarettes.

methodsWe conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6.

resultsA total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups.

conclusionsIn this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Indexed as

Tobacco Use DisorderBiomarkersCreatinineDouble-Blind MethodHumansInhalation ExposureLinear ModelsNicotineSubstance Withdrawal SyndromeTarsTobacco ProductsUnited StatesUnited States Food and Drug AdministrationBiomarkersCreatinineNicotineTars

Identifiers

PMID26422724
PMCPMC4642683
OpenAlexW2269911282

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.