Evidence map›Paper›PMID 22080588›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2012

A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates.

Stephen Rennard, John Hughes, Paul M Cinciripini, Eva Kralikova, Tobias Raupach, Carmen Arteaga, Lisa B St Aubin, Cristina Russ, Flexible Quit Date Study Group

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01926041 (The Effectiveness of Smoking Cessation in Prediabetic Smokers), which is not on this map. Cited by 44 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 12 pooled it
–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.

NCT01926041 naactive not recruitingnot on this mapstarted 2013, after this paper: background citation

The Effectiveness of Smoking Cessation in Prediabetic Smokers

TypeinterventionalSponsorNational Taiwan University HospitalRan2013 to 2027Enrolled589ConditionsDiabetes Mellitus, Cigarette Smoking, PrediabetesArmsVarenicline for tobacco smoking cessation, Individualized counseling about both smoking cessation and weight control techniques
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
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  7. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  8. Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Pooled it
  9. Pooled it
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  11. Smoking cessation interventions for smokers with current or past depression.The Cochrane database of systematic reviews · 2013
    Pooled it
  12. Pooled it
  13. Trial
  14. Trial
  15. A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021
    Trial
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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.

Stephen RennardDivision of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center, Omaha, NE 68198-5910, USA. srennard@unmc.edu
John Hughes
Paul M Cinciripini
Eva Kralikova
Tobias Raupach
Carmen Arteaga
Lisa B St Aubin
Cristina Russ
Flexible Quit Date Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCurrent smoking cessation guidelines recommend setting a quit date prior to starting pharmacotherapy. However, providing flexibility in the date of quitting may be more acceptable to some smokers. The objective of this study was to compare varenicline 1 mg twice daily (b.i.d.) with placebo in subjects using a flexible quit date paradigm after starting medication.

methodsIn this double-blind, randomized, placebo-controlled international study, smokers of ≥10 cigarettes/day, aged 18-75 years, and who were motivated to quit were randomized (3:1) to receive varenicline 1 mg b.i.d. or placebo for 12 weeks. Subjects were followed up through Week 24. Subjects were instructed to quit between Days 8 and 35 after starting medication. The primary endpoint was carbon monoxide-confirmed continuous abstinence during Weeks 9-12, and a key secondary endpoint was continuous abstinence during Weeks 9-24.

resultsOverall, 493 subjects were randomized to varenicline and 166 to placebo. Continuous abstinence was higher for varenicline than for placebo subjects at the end of treatment (Weeks 9-12: 53.1% vs. 19.3%; odds ratio [OR] 5.9; 95% CI, 3.7-9.4; p < .0001) and through 24 weeks follow-up (Weeks 9-24: 34.7% vs. 12.7%; OR 4.4; 95% CI, 2.6-7.5; p < .0001). Serious adverse events occurred in 1.2% varenicline (none were psychiatric) and 0.6% placebo subjects. Fewer varenicline than placebo subjects reported depression-related adverse events (2.3% vs. 6.7%, respectively).

conclusionsVarenicline 1 mg b.i.d. using a flexible quit date paradigm had similar efficacy and safety compared with previous fixed quit date studies.

Indexed as

Tobacco Use Cessation DevicesAdultBenzazepinesDrug Administration ScheduleHumansMiddle AgedNicotinic AgonistsQuinoxalinesSmoking CessationVareniclineBenzazepinesNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID22080588
PMCPMC3281242

What OpenQuestion holds

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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.