Evidence map›Paper›PMID 31195244›Full record

Trial reportJournal of affective disorders2019

Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: Subgroup analysis of a randomized clinical trial.

Jaimee L Heffner, A Eden Evins, Cristina Russ, David Lawrence, Catherine R Ayers, Thomas McRae, Lisa St Aubin, Alok Krishen, Robert West, Robert M Anthenelli

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of affective disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01456936 (A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 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.

NCT01456936 phase4completednot on this map

A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

TypeinterventionalSponsorPfizerRan2011 to 2015Enrolled8,144ConditionsSmoking CessationArmsPlacebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Smoking cessation for improving mental health.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Trial
  4. Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020
    Trial
  5. Article
  6. Antidepressants for smoking cessation.The Cochrane database of systematic reviews · 2023
    Review
  7. Article
  8. Review
  9. 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

10 authors.

Jaimee L HeffnerFred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232; PO Box 19024; Seattle, WA 98109, USA. Electronic address: jheffner@fredhutch.org.
A Eden EvinsMassachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Cristina RussPfizer, New York, NY, USA.
David LawrencePfizer, New York, NY, USA.
Catherine R AyersUniversity of California, San Diego, CA, USA.
Thomas McRaePfizer, New York, NY, USA.
Lisa St AubinPfizer, New York, NY, USA.
Alok KrishenPAREXEL International on behalf of GlaxoSmithKline, Research Triangle Park, NC, USA.
Robert WestUniversity College, London, UK.
Robert M AnthenelliUniversity of California, San Diego, CA, USA.

Funding

Subject CollectionU10AA008401 · NIAAA · SUNY DOWNSTATE MEDICAL CENTER · PI JAY Arnold TISCHFIELD · 1989 to 2026
$162.7M
National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD)U24AG021886 · NIA · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI TATIANA M. FOROUD · 2002 to 2026
$119.8M
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
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
Homeless Female Offenders Returning to the Community: Improving Hopeful FuturesR34DA035409 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI NYAMATHI, ADELINE M · 2014 to 2016
$715k
Cancer Research UKNIAAA NIH HHS R44 AA024643NIAAA NIH HHS U10 AA008401NIA NIH HHS U24 AG021886NIDA NIH HHS K24 DA030443NIDA NIH HHS R34 DA035409NIDA NIH HHS U01 DA041731
6 · The paper itself

Abstract

objectivesPost hoc analyses of EAGLES data to examine safety and efficacy of first-line smoking cessation pharmacotherapies in smokers with bipolar disorders (BD).

methodsSmokers with BD I/II (n = 285; 81.4% with BD I) and a comparison nonpsychiatric cohort (NPC; n = 2794) were randomly assigned to varenicline, bupropion, nicotine replacement therapy (NRT), or placebo for 12 weeks, plus weekly counseling. Primary outcomes were occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates.

resultsFor BD smokers, NPSAE risk differences versus placebo were: varenicline, 6.17 (95% CI: -7.84 to 20.18); bupropion, 4.09 (-8.82 to 16.99); NRT, -0.56 (-12.34 to 11.22). ORs for Weeks 9-12 CA, comparing active medication to placebo among BD smokers were: varenicline, 2.61 (0.68-9.95); bupropion, 1.29 (0.31-5.37), NRT, 0.71 (0.14-3.74). Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC. LIMITATIONS: Study not powered to detect differences in safety and efficacy in the BD subcohort; generalizability limited to stably treated BD without current substance use disorders.

conclusionsSmokers with BD had higher risk of NPSAEs and were less likely to quit overall than NPC smokers. Among smokers with BD, NPSAE risk difference estimates for active treatments versus placebo ranged from 1% lower to 6% higher. Efficacy of varenicline in smokers with BD was similar to EAGLES main outcomes; bupropion and NRT effect sizes were descriptively lower. Varenicline may be a tolerable and effective cessation treatment for smokers with BD.

trial registrationClinicalTrials.gov identifier (https://clinicaltrials.gov/): NCT01456936.

Indexed as

Bipolar DisorderSmoking CessationBupropionCounselingFemaleHumansMaleMiddle AgedNicotinic AgonistsRandom AllocationSmokingTobacco Use Cessation DevicesTreatment OutcomeVareniclineBupropionNicotinic AgonistsVareniclineAbbreviations: BD, bipolar disordersBipolar disorderCA, continuous abstinenceCAR, continuous abstinence rateEfficacyNPC, nonpsychiatric cohortNPSAE, neuropsychiatric adverse eventPPA, point prevalence abstinenceSafetySmoking cessationVarenicline

Identifiers

PMID31195244
PMCPMC8936081

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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.