Evidence map›Paper›PMID 42107144›Full record

Trial reportDrug and alcohol dependence2026

Time-varying mediated effects of the nicotine patch on smoking before and after a quit attempt when it is added to varenicline and counseling.

Nayoung Kim, Timothy B Baker, Donna L Coffman, Megan E Piper, James H Stein, Danielle E McCarthy

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Nayoung KimDepartment of Health Science, College of Human Environmental Science, University of Alabama, Tuscaloosa, AL 35487, USA. Electronic address: nkim12@ua.edu.
Timothy B BakerCenter for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53711, USA; Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53706, USA.
Donna L CoffmanDepartment of Psychology, McCausland College of Arts and Sciences, University of South Carolina, Columbia, SC 29208, USA.
Megan E PiperCenter for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53711, USA; Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53706, USA.
James H SteinDivision of Cardiovascular Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53706, USA.
Danielle E McCarthyCenter for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53711, USA; Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53706, USA.

Funding

Enhancing the Effectiveness of Varenicline Based Smoking Cessation TreatmentR01HL109031 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI BAKER, TIMOTHY B, STEIN, JAMES H · 2011 to 2020
$17.5M
NHLBI NIH HHS R01 HL109031
6 · The paper itself

Abstract

backgroundEven with evidence-based treatment, most people who try to quit smoking return to regular smoking within weeks. Mediation analyses simultaneously test hypotheses about how treatments affect possible smoking determinants and how these determinants may influence smoking risk. Such evidence may inform treatment enhancement.

objectivesConduct secondary analyses that assess the extent to which: a) active vs. placebo nicotine patch used in conjunction with varenicline and counseling affect candidate mediators in the peri-cession period, b) candidate mediators predict next-day smoking, and c) treatment effects on next-day smoking are mediated via candidate mediators.

methodsTime-varying mediation models (TVMM) were fit to ecological momentary assessment data collected nightly from 1202 adults motivated to quit smoking in the 2 weeks preceding and 2 weeks following the target date to quit smoking in a placebo-controlled, double-blinded randomized controlled trial of adjuvant nicotine patch therapy used with varenicline and individual counseling.

resultsAnalyses confirmed the predictive value of hypothesized mediators (cravings to smoke, nicotine withdrawal symptoms, reduced positive affect, and low quitting confidence) on next-day smoking risk, but also found that only positive affect mediated active (vs. placebo) patch effects on next-day abstinence 3-9 days after a target quit day. DISCUSSION: Adding nicotine patches to varenicline and counseling improves positive affect in ways that predict lower next-day smoking risk in the first days of attempts to quit smoking but does not significantly improve withdrawal management or sustain confidence in quitting.

Indexed as

CounselingNicotinic AgonistsSmokingSmoking CessationSmoking Cessation AgentsTobacco Use Cessation DevicesVareniclineAdultCombined Modality TherapyDouble-Blind MethodFemaleHumansMaleMiddle AgedNicotine Replacement TherapyTime FactorsNicotinic AgonistsSmoking Cessation AgentsVareniclineNicotine replacement therapySmoking cessationTime-varying mediation modelingTreatment refinementVareniclineWithdrawal

Identifiers

PMID42107144
PMCPMC13505347

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.