Evidence map›Paper›PMID 30811371›Full record

Trial reportJournal of clinical psychopharmacology

Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial.

A Eden Evins, Neal L Benowitz, Robert West, Cristina Russ, Thomas McRae, David Lawrence, Alok Krishen, Lisa St Aubin, Melissa Culhane Maravic, Robert M Anthenelli

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Antidepressants for smoking cessation.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Trial
  5. Trial
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  10. Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Trial
  11. Review
  12. Article
  13. Article
  14. Review
  15. Smoking cessation pharmacotherapy; varenicline or bupropion?Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Review
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  17. Article
  18. Article
  19. Review
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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

10 authors at 5 institutions in 2 countries.

A Eden Evins
Neal L BenowitzDepartment of Medicine, University of California, San Francisco, CA.
Robert WestDepartment of Behavioural Science and Health, University College London, London, United Kingdom.
Cristina RussPfizer, New York, New York.
Thomas McRaePfizer, New York, New York.
David LawrencePfizer, New York, New York.
Alok Krishen
Lisa St AubinPfizer, New York, New York.
Melissa Culhane MaravicDepartment of Psychiatry, Massachusetts General Hospital, Boston, MA.
Robert M AnthenelliDepartment of Psychiatry, University of California, San Diego, CA.
Pfizer (United States) · USMassachusetts General Hospital · USUniversity College London · GBUniversity of California, San Diego · USUniversity of California, San Francisco · US

Funding

Preclinical studies for the development of selective mGlu2 positive allosteric modulators to treat substance use disordersU01DA041731 · NIDA · SANFORD BURNHAM PREBYS MEDICAL DISCOVERY INSTITUTE · PI COSFORD, NICHOLAS DAVID · 2017 to 2019
$10.8M
INIA: Stress, Anxiety of Alcohol AbuseU01AA013641 · NIAAA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI GRANT, KATHLEEN A · 2002 to 2015
$8.8M
Mentoring in Addiction Treatment ResearchK24DA030443 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI EVINS, A EDEN · 2010 to 2020
$2.0M
Wearable Biosensors for Real-time Blood Alcohol MonitoringR44AA024643 · NIAAA · BIOLINQ INCORPORATED · PI ANTHENELLI, ROBERT M, WANG, JOSEPH · 2015 to 2017
$1.2M
NIAAA NIH HHS R44 AA024643NIAAA NIH HHS U01 AA013641NIDA NIH HHS K24 DA030443NIDA NIH HHS U01 DA041731
6 · The paper itself

Abstract

backgroundNeuropsychiatric safety and relative efficacy of varenicline, bupropion, and transdermal nicotine patch (NRT) in those with psychiatric disorders are of interest.

methodsWe performed secondary analyses of safety and efficacy outcomes by psychiatric diagnosis in EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), a 12-week, randomized, double-blind, triple-dummy, placebo- and active (NRT)-controlled trial of varenicline and bupropion with 12-week follow-up, in a subset population, n = 4092, with a primary psychotic (n = 390), anxiety (n = 792), or mood (n = 2910) disorder. Primary end-point parameters were incidence of prespecified moderate and severe neuropsychiatric adverse events (NPSAEs) and weeks 9 to 12 continuous abstinence rates (9-12CAR).

resultsThe observed NPSAE incidence across treatments was 5.1% to 6.3% in those with a psychotic disorder, 4.6% to 8.0% in those with an anxiety disorder, and 4.6% to 6.8% in those with a mood disorder. Neither varenicline nor bupropion was associated with significantly increased NPSAEs relative to NRT or placebo in the psychiatric cohort or any psychiatric diagnostic subcohort. There was a significant effect of treatment on 9-12CAR (P < 0.0001) and no significant treatment-by-diagnostic subcohort interaction (P = 0.24). Abstinence rates with varenicline were superior to bupropion, NRT, and placebo, and abstinence with bupropion and NRT was superior to placebo. Within-diagnostic subcohort comparisons of treatment efficacy yielded estimated odds ratios for 9-12CAR versus placebo of greater than 3.00 for varenicline, greater than 1.90 for bupropion, and greater than 1.80 for NRT for all diagnostic groups.

conclusionsVarenicline, bupropion, and nicotine patch are well tolerated and effective in adults with psychotic, anxiety, and mood disorders. The relative effectiveness of varenicline, bupropion, and NRT versus placebo did not vary across psychiatric diagnoses.

Indexed as

Tobacco Use Cessation DevicesAdultAnxiety DisordersBupropionDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedMood DisordersPsychotic DisordersSmoking CessationSmoking Cessation AgentsTreatment OutcomeVareniclineBupropionSmoking Cessation AgentsVarenicline

Identifiers

PMID30811371
PMCPMC6488024
OpenAlexW2916429144

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.