Evidence map›Paper›PMID 25727442›Full record

Trial reportAddiction (Abingdon, England)2015

An exploratory short-term double-blind randomized trial of varenicline versus nicotine patch for smoking cessation in women.

Kevin M Gray, Erin A McClure, Nathaniel L Baker, Karen J Hartwell, Matthew J Carpenter, Michael E Saladin

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2015
    Trial
  5. Article
  6. Article
  7. Article
  8. Review
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 at 3 institutions in 1 country.

Kevin M GrayDepartment of Psychiatry and Behavioral Sciences.
Erin A McClureDepartment of Psychiatry and Behavioral Sciences.
Nathaniel L BakerDepartment of Public Health Sciences.
Karen J HartwellDepartment of Psychiatry and Behavioral Sciences.
Matthew J CarpenterDepartment of Psychiatry and Behavioral Sciences.
Michael E SaladinDepartment of Psychiatry and Behavioral Sciences.
Medical University of South Carolina · USMUSC Hollings Cancer Center · USRalph H. Johnson VA Medical Center · US

Funding

Vocational Training for Drug Dependent WomenP50DA016511 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2002 to 2017
$14.5M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
Stimulus Control and Trajectories of Adolescent SmokingK23DA020482 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CARPENTER, MATTHEW J · 2007 to 2011
$869k
NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1TR000062NCRR NIH HHS UL1 RR029882NCRR NIH HHS UL1RR029882NIDA NIH HHS K23 DA020482NIDA NIH HHS K23DA020482NIDA NIH HHS P50 DA016511NIDA NIH HHS P50DA16511
6 · The paper itself

Abstract

aimsWithin a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch.

designDouble-blind double-dummy randomized trial.

settingSingle-site out-patient research clinic in the United States.

participantsFemale smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months (n=140).

interventionsParticipants were randomized to receive a 4-week course of (a) varenicline tablets and placebo patches (n = 67) or (b) placebo tablets and nicotine patches (n=73). Two brief cessation counseling sessions were provided for all participants. MEASUREMENTS: The outcome of primary clinical interest was 2-week end-of-treatment abstinence. Secondary outcomes included 1- and 4-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring 4 weeks after treatment conclusion. Breath carbon monoxide (≤ 10 parts per million) was used to confirm biochemically self-reported abstinence.

findingsTwo-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch participants [odds ratio (OR) = 2.7, 95% confidence interval (CI)=1.3-6.0, P=0.011]. One-week (44.8 versus 20.6%, OR=3.1, 95% CI=1.5-6.6, P=0.003) and 4-week (22.4 versus 9.6%, OR=2.7, 95% CI=1.0-7.2, P=0.043) end-of-treatment abstinence similarly favored varenicline, although post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9 versus 13.7%, OR=2.0, 95% CI=0.8-4.7, P=0.126).

conclusionIn an exploratory 4-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up.

Indexed as

Tobacco Use Cessation DevicesAdolescentAdultDouble-Blind MethodFemaleHumansMiddle AgedNicotinic AgonistsSmoking CessationSmoking PreventionTreatment OutcomeVareniclineYoung AdultNicotinic AgonistsVareniclineGendernicotinenicotine patchNRTpharmacotherapyrandomized clinical trialtobaccovareniclinewomen

Identifiers

PMID25727442
PMCPMC4430389
OpenAlexW2146257157

What OpenQuestion holds

Textmetadata
LicenceTDM
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.