Evidence map›Paper›PMID 34242666›Full record

Trial reportPreventive medicine2021

Cumulative vulnerabilities as a potential moderator of response to reduced nicotine content cigarettes.

Stephen T Higgins, Michael DeSarno, Janice Y Bunn, Diann E Gaalema, Adam M Leventhal, Danielle R Davis, Joanna M Streck, Roxanne F Harfmann, Catherine Markesich, Eva Orr and 5 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Preventive medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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.

NCT02232737 phase1 / phase2completednot on this map

Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

TypeinterventionalSponsorBrown UniversityRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
NCT02250534 phase1 / phase2completednot on this map

Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

TypeinterventionalSponsorUniversity of VermontRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
NCT02250664 phase1 / phase2completednot on this map

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers

TypeinterventionalSponsorUniversity of VermontRan2016 to 2019Enrolled775ConditionsTobacco Use DisorderArmsVery low nicotine content cigarettes
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
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  3. Unmet Health-Related Social Needs Among Black Adults Who Smoke.Journal of racial and ethnic health disparities · 2026
    Article
  4. Article
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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

15 authors.

Stephen T HigginsVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA. Electronic address: stephen.higgins@uvm.edu.
Michael DeSarnoVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Janice Y BunnVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Diann E GaalemaVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Adam M LeventhalDepartment of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Danielle R DavisVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Joanna M StreckVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Roxanne F HarfmannVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Catherine MarkesichVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Eva OrrVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Stacey C SigmonVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Sarah H HeilVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.
Jennifer W TideyVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA.
Dustin LeeVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
John R HughesVermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA.

Funding

USC Tobacco Center of Regulatory ScienceU54CA180905 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI John R Monterosso · 2018 to 2026
$39.0M
Vermont Center on Behavior and HealthP20GM103644 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2013 to 2022
$21.3M
University of Vermont Tobacco Center of Regulatory ScienceU54DA036114 · NIDA · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HIGGINS, STEPHEN T · 2018 to 2022
$19.4M
Project 4: Comprehension of Health Risks in More and Less Arousing Affe p240-275P50CA180908 · NCI · OHIO STATE UNIVERSITY · PI SHIELDS, PETER G., WEWERS, MARY ELLEN · 2013 to 2017
$18.9M
Leadership and Administrative Core (p 188-304)U54CA189222 · NCI · WESTAT, INC. · PI ABRAMS, DAVID BRIAN, ROSENTHAL, JEANNE · 2014 to 2018
$8.5M
Tobacco Use Treatment Research for Vulnerable PopulationsK24DA048160 · NIDA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Adam Matthew Leventhal · 2019 to 2026
$1.4M
NCI NIH HHS P50 CA180908NCI NIH HHS U54 CA180905NCI NIH HHS U54 CA189222NIDA NIH HHS K24 DA048160NIDA NIH HHS U54 DA036114NIGMS NIH HHS P20 GM103644
6 · The paper itself

Abstract

Risk for smoking increases in a summative manner corresponding to the number of co-occurring vulnerabilities present (cumulative vulnerability). We examined whether cumulative vulnerabilities moderate response to reduced nicotine content cigarettes in a secondary analysis of results from 775 participants in three 12-week randomized clinical trials examining research cigarettes varying in nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco). Participants were categorized as having 0-1, 2-3, or ≥ 4 cumulative vulnerabilities. Vulnerabilities included: rural residence, current substance use disorder, current affective disorder, low educational attainment, poverty, unemployment, physical disability. The primary outcome was total cigarettes per day (CPD) during Week 12; secondary outcomes included CPD across weeks, toxin exposure, dependence severity, craving/withdrawal (17 dependent measures). Results were analyzed using repeated measures analysis of covariance and growth-curve modeling. Total CPD during Week 12 increased as cumulative-vulnerability increased (P = 0.004), and decreased as nicotine content decreased (P < 0.001), with no significant interaction of cumulative vulnerability and dose (P = 0.67). Effects on other outcomes generally followed that same pattern. The only exception across the other outcomes was on Questionnaire-on-Smoking-Urges Factor-2 ratings for usual-brand cigarettes where cumulative vulnerability, dose, and time interacted (P = 0.007), with craving at the 0.4 and 2.4 mg/g doses decreasing over time, but inconsistently across vulnerability categories. Overall, we saw little evidence that cumulative vulnerabilities moderate response to reduced nicotine content cigarettes suggesting that a policy reducing nicotine content in cigarettes to minimally addictive levels could benefit even highly vulnerable smokers including those residing in rural or other regions with overrepresentation of co-occurring vulnerabilities. Clinicaltrials.gov identifiers: NCT02232737, NCT02250664, NCT02250534.

Indexed as

Smoking CessationTobacco ProductsTobacco Use DisorderHumansNicotineSmokersNicotineCigarette smokingCumulative vulnerabilityNicotine dependenceReduced nicotine content cigarettesToxin exposureVulnerable populations

Identifiers

PMID34242666
PMCPMC8906391

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.