Evidence map›Paper›PMID 29986268›Full record

Trial reportDrug and alcohol dependence2018

Predicting smoking abstinence with biological and self-report measures of adherence to varenicline: Impact on pharmacogenetic trial outcomes.

Annie R Peng, Robert Schnoll, Larry W Hawk, Paul Cinciripini, Tony P George, Caryn Lerman, Rachel F Tyndale

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01314001 (Pharmacogenetics of Nicotine Addiction Treatment), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

NCT01314001 phase3completednot on this map

Pharmacogenetics of Nicotine Addiction Treatment (PNAT)

TypeinterventionalSponsorUniversity of PennsylvaniaRan2010 to 2014Enrolled1,246ConditionsNicotine AddictionArmsVarenicline, Placebo, Transdermal Nicotine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Stability of Varenicline Concentration in Saliva Over 21 Days at Three Storage Temperatures.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
    Article
  9. Article
  10. Article
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

7 authors.

Annie R PengDepartment of Pharmacology and Toxicology, University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. Electronic address: a.peng@mail.utoronto.ca.
Robert SchnollDepartment of Psychiatry and Abramson Cancer Center, University of Pennsylvania, 3535 Market Street, 4th Floor, Philadelphia, PA, 19104, United States. Electronic address: schnoll@mail.med.upenn.edu.
Larry W HawkDepartment of Psychology, State University of New York at Buffalo, 230 Park Hall, The State University of New York, Buffalo, NY, 14260-4110, United States. Electronic address: lhawk@buffalo.edu.
Paul CinciripiniDepartment of Behavioral Science, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Houston, TX, 77030, United States. Electronic address: pcinciri@mdanderson.org.
Tony P GeorgeAddictions Division, Centre for Addiction and Mental Health and Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, 100 Stokes Street BGB 3288, Toronto, ON, M6J 1H4, Canada. Electronic address: tony.george@camh.ca.
Caryn LermanDepartment of Psychiatry and Abramson Cancer Center, University of Pennsylvania, 3535 Market Street, 4th Floor, Philadelphia, PA, 19104, United States. Electronic address: clerman@upenn.edu.
Rachel F TyndaleDepartment of Pharmacology and Toxicology, University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada; Addictions Division, Centre for Addiction and Mental Health and Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, 100 Stokes Street BGB 3288, Toronto, ON, M6J 1H4, Canada. Electronic address: r.tyndale@utoronto.ca.

Funding

University of Toronto Coordinating Genetics Core & Clinical Trial SiteU01DA020830 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI LERMAN, CARYN, TYNDALE, RACHEL FYNVOLA · 2005 to 2014
$22.4M
CIHR FDN-154294CIHR PJT-153286NIDA NIH HHS U01 DA020830
6 · The paper itself

Abstract

introductionAdherence to pharmacotherapies for tobacco dependence, such as varenicline, is necessary for effective treatment. The relationship between varenicline adherence, determined by commonly used indirect (i.e., self-reported pill counts) and infrequently used direct (i.e., varenicline levels) methods, and abstinence outcomes have not been previously examined, nor has their impact on the outcomes of a genetically randomized clinical trial been assessed.

methodsAt Week 1 following target quit date, self-reported pill count and salivary varenicline levels were obtained from participants (N = 376) in a smoking cessation clinical trial (NCT01314001). Point-prevalence abstinence was biochemically-verified by salivary cotinine at Week 1 and by exhaled carbon monoxide at Week 1, end-of-treatment, 6 and 12 months following treatment. Blood nicotine metabolite ratio (NMR) was obtained at baseline.

resultsAdherent individuals based on varenicline levels were significantly more likely to be abstinent than non-adherent individuals at Week 1 (odds ratios [ORs] 1.92-3.16, p's≤0.006), end-of-treatment (OR = 2.53, p = .004), and six months following treatment (OR = 2.30, p = .03). In contrast, pill counts did not consistently predict abstinence. Including direct measures of adherence enhanced the association between rate of nicotine metabolism (NMR) and end-of-treatment abstinence; normal metabolizers (NMR ≥ 0.31) were significantly more likely than slow metabolizers (NMR < 0.31) to be abstinent at end-of-treatment (OR = 2.00, p = .005).

conclusionAdherence based on salivary varenicline, rather than on pill counts, is predictive of Week 1 abstinence, irrespective of the biomarker of abstinence assessed, and of long-term abstinence. Direct measures of adherence enhance the ability to assess the impact of a biomarker or genetic marker on abstinence outcomes.

Indexed as

Medication AdherenceAdultFemaleHumansMaleMiddle AgedNicotineNicotinic AgonistsPharmacogeneticsPredictive Value of TestsSelf ReportSmokingSmoking CessationTobacco Use DisorderTreatment OutcomeVareniclineNicotineNicotinic AgonistsVareniclineComplianceSmoking cessationTreatment adherenceTreatment outcomeVarenicline

Identifiers

PMID29986268
PMCPMC6085881

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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.