Trial reportAddiction (Abingdon, England)2021
Comparative effects of varenicline or combination nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt.
Trial report in Addiction (Abingdon, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation.The Cochrane database of systematic reviews · 2023Pooled it
- Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023Pooled it
- Time-varying mediated effects of the nicotine patch on smoking before and after a quit attempt when it is added to varenicline and counseling.Drug and alcohol dependence · 2026Trial
- 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 · 2025Trial
- Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022Trial
- Time-Varying Mediation of Pharmacological Smoking Cessation Treatments on Smoking Lapse via Craving, Cessation Fatigue, and Negative Mood.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022Trial
- Perspectives in Psychopharmacology.Focus (American Psychiatric Publishing) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
BACKGROUND AND
aimsThe phase-based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre-cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C-NRT) relative to nicotine patch monotherapy on pre-cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators.
designSecondary mediation analysis of data from the open-label, randomized Wisconsin Smokers' Health Study 2, a comparative effectiveness trial of varenicline or C-NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach.
settingResearch clinics in Madison and Milwaukee, Wisconsin, USA.
participantsA total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6).
interventionsTwelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling. MEASUREMENTS: The primary abstinence outcome was biochemically verified 7-day point-prevalence abstinence 4 weeks post-target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre-cessation phase) to 4 weeks after (cessation phase) the TQD.
findingsPre-cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34-0.79], smoking expectancies (aOR = 0.46-0.79) and quitting motivation (aOR = 1.35-7.21) significantly predicted 4-week post-TQD abstinence (P < 0.05). Significant varenicline mediation occurred via greater suppression in pre-cessation craving [mediated effect (ab) = 0.09, standard error (SE) = 0.03, 95% confidence interval (CI) = 0.04-0.14] and smoking expectancies (ab = 0.06, SE = 0.02, 95% CI = 0.02-0.12). C-NRT mediation occurred via greater reduction in pre-post-TQD changes in craving (ab = 0.04, SE = 0.02, 95% CI = 0.01-0.08) and expectancies (ab = 0.03, SE = 0.02, 95% CI = 0.001-0.07), relative to patch monotherapy.
conclusionAmong adult smokers seeking to quit, varenicline seems to work through its effects on suppression of craving and smoking expectancies pre-cessation while combination nicotine replacement therapy mediation seems to work through cessation-related reduction in craving and smoking expectancies changes.
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