Evidence map›Paper›PMID 27367436›Full record

Trial reportAddiction (Abingdon, England)2016

Estimations and predictors of non-compliance in switchers to reduced nicotine content cigarettes.

Natalie Nardone, Eric C Donny, Dorothy K Hatsukami, Joseph S Koopmeiners, Sharon E Murphy, Andrew A Strasser, Jennifer W Tidey, Ryan Vandrey, Neal L Benowitz

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing 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

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

  1. 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
  2. The Impact of Three Alternate Nicotine-Delivery Products on Combusted Cigarette Use: A Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Trial
  3. Reactions to a Nicotine Reduction Policy Among Adolescents Who Smoke: A Qualitative Study.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2024
    Trial
  4. Trial
  5. Trial
  6. 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
  7. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2020
    Trial
  8. Mouth-Level Nicotine Intake Estimates from Discarded Filter Butts to Examine Compensatory Smoking in Low Nicotine Cigarettes.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2020
    Trial
  9. The Impact of Gradual and Immediate Nicotine Reduction on Subjective Cigarette Ratings.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Trial
  10. Effects of 6-Week Use 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 · 2019
    Trial
  11. Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine.American journal of preventive medicine · 2019
    Trial
  12. Age Moderates Smokers' Subjective Response to Very-Low Nicotine Content Cigarettes: Evidence from a Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Natalie NardoneUniversity of California, San Francisco, Department of Medicine, San Francisco, CA, USA.
Eric C DonnyUniversity of Pittsburgh, Department of Psychology, Pittsburgh, PA, USA.
Dorothy K HatsukamiUniversity of Minnesota, Department of Psychiatry, Minneapolis, MN, USA.
Joseph S KoopmeinersUniversity of Minnesota, School of Public Health, Minneapolis, MN, USA.ORCID 0000-0001-6147-3168
Sharon E MurphyUniversity of Minnesota, Department of Biochemistry, Molecular Biology and Biophysics, Minneapolis, MN, USA.
Andrew A StrasserUniversity of Pennsylvania, Department of Psychiatry, Philadelphia, PA, USA.
Jennifer W TideyBrown University, Department of Psychiatry and Human Behavior, Providence, RI, USA.
Ryan VandreyJohns Hopkins University, Department of Psychiatry and Behavioral Sciences, Behavioral Pharmacology Research Unit, Baltimore, MD, USA.
Neal L BenowitzUniversity of California, San Francisco, Department of Medicine and Bioengineering and Therapeutic Sciences, San Francisco, CA, 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 HECHT, STEPHEN S · 2011 to 2022
$64.7M
Safety of Nicotine Reduction StrategyR01CA078603 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BENOWITZ, NEAL L · 1999 to 2009
$4.6M
NCI NIH HHS P30 CA077598NCI NIH HHS R01 CA078603NIDA NIH HHS U54 DA031659
6 · The paper itself

Abstract

BACKGROUND AND

aimsClinical trials on the impact and safety of reduced nicotine content cigarettes (RNCs) are ongoing, and an important methodological concern is participant compliance with smoking only RNCs. Our aims were to measure non-compliance biochemically with urine cotinine (COT) and total nicotine equivalents (TNEs), compare with self-reported non-compliance and identify associated covariates.

designSecondary analysis of a double-blind, parallel, randomized clinical trial.

settingResearch centers from the United States, enrolling participants from June 2013 to July 2014.

participantsVolunteer sample of 242 participants (55% Caucasian), average age of 41.2 years, smoking at least five cigarettes per day (CPD).

interventionSmoking very low nicotine cigarettes (VLNCs; 0.4 mg nicotine/g tobacco) for 6 weeks. MEASUREMENTS: The primary outcome was biochemically verified non-compliance, measured as thresholds of COT/CPD and TNE/CPD ratios, considering changes in nicotine content from conventional levels to VLNCs, and as an absolute threshold of week 6 TNEs. Self-reported non-compliance was measured via daily phone calls. Key predictors included age, sex, race, menthol preference, nicotine metabolite ratio, time to first cigarette, dependence, CPD, TNEs, tar level and cigarette evaluation.

findingsEstimates of non-compliance with smoking the VLNCs exclusively include: the biochemical ratios (both 78%), the week 6 TNE threshold (76%) and self-report (39%). Of the key covariates, age, dependence and cigarette evaluations of satisfaction were significant; for age, younger participants more likely to be non-compliant [P = 0.01; odds ratio (OR) = 0.98, 95% confidence interval (CI) = 0.96-0.99]. Dependence was associated significantly with self-reported non-compliance (P = 0.01; OR = 1.28, 95% CI = 1.06-1.55). Cigarette evaluations of satisfaction were associated significantly with non-compliance (P = 0.001; OR = 0.71, 95% CI = 0.61-0.82).

conclusionsAmong smokers volunteering to smoke only very low nicotine cigarettes for 6 weeks, non-compliance was common and biochemical assessments detected more cases of non-compliance than self-report. Despite high levels of non-compliance, smokers reduced their intake of nicotine by an average of 60%.

Indexed as

Tobacco ProductsAdultBiomarkersDouble-Blind MethodFemaleGanglionic StimulantsHealthy VolunteersHumansMaleNicotinePatient ComplianceSalivaSmoking ReductionUrinalysisBiomarkersGanglionic StimulantsNicotineBiomarkerscigarette smokingcotininenicotine reductionreduced nicotine content cigarettestotal nicotine equivalents

Identifiers

PMID27367436
PMCPMC5203964

What OpenQuestion holds

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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.