Evidence map›Paper›PMID 33249458›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2021

A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation.

Matthew J Carpenter, Kevin M Gray, Amy E Wahlquist, Karen Cropsey, Michael E Saladin, Brett Froeliger, Tracy T Smith, Benjamin A Toll, Jennifer Dahne

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% 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.

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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Varenicline Over-The-Counter Trial on Efficacy and Safety.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2024
    Trial
  5. Trial
  6. 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

9 authors at 4 institutions in 1 country.

Matthew J CarpenterDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.
Kevin M GrayDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.
Amy E WahlquistDepartment of Public Health Sciences, MUSC, Charleston, SC.
Karen CropseyDepartment of Psychiatry, University of Alabama, Birmingham, UK.
Michael E SaladinDepartment of Health Sciences and Research, MUSC, Charleston, SC.
Brett FroeligerDepartment of Psychiatry, University of Missouri, Columbia, MI.
Tracy T SmithDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.
Benjamin A TollDepartment of Public Health Sciences, MUSC, Charleston, SC.
Jennifer DahneDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.
MUSC Hollings Cancer Center · USMedical University of South Carolina · USUniversity of Alabama · USUniversity of Missouri · US

Funding

Tumor Immunology and Microenvironment Research ProgramP30CA068485 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Ben Ho Park · 1995 to 2026
$172.8M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Translational Science Laboratory Shared ResourceP30CA138313 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI John J Lemasters · 2009 to 2026
$42.7M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR001450 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T., FLUME, PATRICK A · 2015 to 2024
$41.1M
Development and Testing of a Depression-Specific Behavioral Activation Mobile App Paired with Nicotine Replacement Therapy Sampling for Smoking Cessation Treatment Via Primary CareK23DA045766 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DAHNE, JENNIFER RENEE · 2018 to 2022
$1.0M
Impact of e-cigarette characteristics on reinforcement and tobacco use patterns among current smokersK01DA047433 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SMITH, TRACY TAYLOR · 2019 to 2023
$988k
NCATS NIH HHS UL1 TR001450NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA068485NCI NIH HHS P30 CA138313NIDA NIH HHS K01 DA047433NIDA NIH HHS K23 DA045766
6 · The paper itself

Abstract

introductionMedication sampling is a clinically useful tool to engage smokers in the quitting process. Whether varenicline is suitable for sampling purposes is unclear. The purpose of this study was to examine the feasibility, uptake, and preliminary outcomes of varenicline sampling.

methodsSmokers (N = 99), both motivated to quit and not, were recruited and randomized to varenicline sampling versus not, with 12 week follow-up. The intervention consisted of mailing one-time samples of varenicline (lasting 2-4 wks), with minimally suggestive guidance on use.

resultsUptake of varenicline was strong, at 2 weeks (54% any use, 66% daily use) and 4 weeks (38%, 46%), with 58% of medication users seeking additional medication. Most users followed conventional titration patterns, self-titrating from 0.5 mg to 2 mg. Relative to control, varenicline sampling increased motivation (p = 0.006) and confidence to quit (p = 0.02), and decreased cigarette smoking (p = 0.02). Smokers receiving varenicline samples were significantly more likely to achieve 50% reduction in cigarettes per day (CPD), both immediately following the sampling exercise (Adjusted Odds Ratio [AOR] = 4.12; 95% CI: 1.39 to 12.17) and at final follow-up (AOR = 4.50; 95% CI: 1.56 to 13.01). Though cessation outcomes were not statistically significant, there was a 1.5 to 3-fold increase in quit attempts and abstinence from varenicline sampling throughout follow-up. These outcomes were comparable among smokers motivated to quit and not.

conclusionsUnguided, user-driven sampling of varenicline sampling is a concrete behavioral exercise that is feasible to do and seems to suggest clinical utility. Sampling is a pragmatic clinical approach to engage more smokers in quitting. IMPLICATIONS: Use of evidence-based pharmacotherapies for smoking cessation is low. Medication sampling is a pragmatic behavioral exercise that allows smokers to experience the benefits of using them, while promoting positive downstream effects towards quitting. While previous studies have shown that nicotine replacement therapy (NRT) sampling is viable and effective, whether this extends to varenicline is unclear. Results from this trial demonstrate that varenicline sampling is feasible, safe, and suggestive of clinically important steps toward quitting, deserving of a larger trial. CLINICAL

trial registrationNCT #03742154.

Indexed as

Electronic Nicotine Delivery SystemsSmoking CessationAdultFemaleHumansMalePilot ProjectsTobacco Use Cessation DevicesVareniclineVarenicline

Identifiers

PMID33249458
PMCPMC8150130
OpenAlexW3108687171

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.