Evidence map›Paper›PMID 31106492›Full record

Trial reportAddiction (Abingdon, England)2019

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.

Elias M Klemperer, John R Hughes, Peter W Callas, Joy A Benner, Nicholas E Morley

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. It is linked to trial NCT03060083 (A Randomized Trial to Compare Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 41% 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.

NCT03060083 phase2 / phase3completednot on this map

A Randomized Trial to Compare Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day

TypeinterventionalSponsorUniversity of VermontRan2017 to 2018Enrolled74ConditionsTobacco Use DisorderArmsVery low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT), Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

5 authors at 1 institution in 1 country.

Elias M KlempererVermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.ORCID 0000-0002-7985-0870
John R HughesVermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.ORCID 0000-0001-9893-7843
Peter W CallasDepartment of Biostatistics, University of Vermont, Burlington, VT, USA.
Joy A BennerVermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.
Nicholas E MorleyVermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.
University of Vermont · US

Funding

University of Vermont Tobacco Center of Regulatory ScienceU54DA036114 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2018 to 2022
$19.4M
Vermont Center on Tobacco Regulatory ScienceP50DA036114 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2013 to 2017
$19.1M
TRAINING IN BEHAV. PHARMACOLOGY OF HUMAN DRUG DEPENDENCET32DA007242 · NIDA · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI HEIL, SARAH H, HIGGINS, STEPHEN T · 1990 to 2025
$8.2M
Natural History of Attempts to Stop SmokingR01DA025089 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HUGHES, JOHN R · 2008 to 2010
$1.3M
NIDA NIH HHS P50 DA036114NIDA NIH HHS R01 DA025089NIDA NIH HHS T32 DA007242NIDA NIH HHS U54 DA036114
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.

designA two-arm, individually randomized open-label trial.

settingCommunity setting, Vermont, USA.

participantsSixty-eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days.

interventionsAll participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1 week (baseline). Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4 weeks by either (a) transitioning to lower nicotine content cigarettes (n = 36) or (b) reducing the number of full nicotine cigarettes (n = 32). All participants received nicotine patches. MEASUREMENTS: The primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale.

findingsDependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).

conclusionsTransitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4-week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch.

Indexed as

Tobacco ProductsTobacco Use Cessation DevicesAdultCigarette SmokingFemaleHumansMaleMiddle AgedNicotineNicotinic AgonistsSmoking CessationSmoking ReductionTobacco Use DisorderNicotineNicotinic AgonistsCigarette smokingharm reductionnicotine dependencereductiontobacco regulatory policyvery low nicotine content cigarettes

Identifiers

PMID31106492
PMCPMC6682423
OpenAlexW2945126491

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.