Clinical trial NCT01456936: Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation
psychiatric disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-10-21
Enrollment: 8144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Eligibility criteria: Inclusion Criteria:

* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

* Subjects with a past or current diagnosis of one of the following disorders:

  a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Primary outcomes:
measure: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Estimated NPS AE Rate (%), by Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcomes:
measure: Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of the Components of NPS AE Primary Endpoint (Overall)
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
timeFrame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
timeFrame: Baseline to Week 24
measure: HADS Total Score, Psychiatric History Cohort
timeFrame: Baseline to Week 24
measure: HADS Total Score (Overall)
timeFrame: Baseline to Week 24
measure: Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
timeFrame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
timeFrame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
timeFrame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
measure: Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit
timeFrame: Baseline to Week 24
measure: CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
timeFrame: Week 9 through Week 12
measure: CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
timeFrame: Week 9 through Week 12
measure: CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
timeFrame: Week 9 through Week 12
measure: CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
timeFrame: Week 9 through Week 24
measure: CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
timeFrame: Week 9 through Week 24
measure: CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
timeFrame: Week 9 through Week 24
measure: 7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
timeFrame: 24 Weeks
measure: 7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
timeFrame: 24 Weeks
measure: 7-Day Point Prevalence of Abstinence (Overall)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: NoesisPharma Research
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials
state: California
city: La Jolla
country: United States
facility: Pacific Treatment and Research Center UC San Diego Health System
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at University of California, Los Angeles
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions,Inc.
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Psychiatric Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Meridian
country: United States
facility: Northwest Neurobehavioral Health
state: Idaho
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: Indianaopolis
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Davis Clinic, Incorporated
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Metairie
country: United States
facility: A Professional Corporation dba The Center for Sexual Health
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Lewiston
country: United States
facility: Community Clinical Services
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Milford
country: United States
facility: Milford Emergency Associates, Incorporated
state: Massachusetts
city: Milford
country: United States
facility: Rahim Shafa, MD
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota- TC
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: St.Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute Clinical Trials LLC
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Cary
country: United States
facility: Tooley Group
state: North Carolina
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Broomall
country: United States
facility: Southeastern PA Medical Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Lincoln
country: United States
facility: East Side Clinical Laboratory
state: Rhode Island
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical NeuroScience Solutions, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Nashville
country: United States
facility: James G. Kyser, MD
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Newport News
country: United States
facility: Peninsula Psychotherapy Center, LLC
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Ciudad Autonoma de Bs. As
country: Argentina
facility: Centro Medico Dra. De Salvo
state: Buenos Aires
city: Mataderos
country: Argentina
facility: Centro de Investigacion Clinica WM
state: Buenos Aires
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Monash Alfred Psychiatry Research Centre
state: Victoria
city: Fortaleza
country: Brazil
facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes
state: CE
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
state: RS
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
state: SP
city: Bourgas
country: Bulgaria
facility: Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
city: Kazanlak
country: Bulgaria
facility: MBAL Dr. Hristo Stambolski EOOD
city: Novi Iskar
country: Bulgaria
facility: DPB Sv. Ivan Rilski
city: Pleven
country: Bulgaria
facility: UMBAL Dr. Georgi Stranski EAD,
city: Plovdiv
country: Bulgaria
facility: UMBAL Sveti Georgi EAD, Klinika po psihiatriya
city: Ruse
country: Bulgaria
facility: SBALPFZ - Ruse EOOD
city: Ruse
country: Bulgaria
facility: Tsentar za psihichno zdrave - Ruse EOOD
city: Sofia
country: Bulgaria
facility: Meditsinski Tsentar ¿Sveti Naum¿ EOOD
city: Sofia
country: Bulgaria
facility: MHATNP Sveti Naum SJsc.
city: Troyan
country: Bulgaria
facility: Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Mississauga
country: Canada
facility: Medical Research Associates
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Felix Yaroshevsky
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
city: Toronto
country: Canada
facility: Centre of Addiction and Mental Health Pharmacy
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Talca
country: Chile
facility: Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
state: Maule
city: Quillota
country: Chile
facility: Centro Respiratorio Integral (CENRESIN Ltda.)
state: Valparaiso, V Region
city: Ballerup
country: Denmark
facility: CCBR A/S
city: Vejle
country: Denmark
facility: CCBR A/S
city: Espoo
country: Finland
facility: Mehiläinen Leppävaara
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu Oy
city: Nummela
country: Finland
facility: Mehiläinen Nummela
city: Oulu
country: Finland
facility: Oulu Mentalcare
city: Pori
country: Finland
facility: Porin Lääkäritalo Oy
city: Turku
country: Finland
facility: PEL, Psykiatrian ErikoiLääkärit
city: Leipzig
country: Germany
facility: ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
state: Sachsen
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: emovis GmbH
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Muenchen
country: Germany
facility: Ludwig Maximilians-Universitaet Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinik Tuebingen
city: Mexico
country: Mexico
facility: Centro Respiratorio de Mexico S.C.
state: D.f.
city: Colonia Hipodromo Condesa
country: Mexico
facility: Consultarios de Medicina Especializada del Sector Privado
state: Mexico DF
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
state: Michoacan
city: Monterrey
country: Mexico
facility: Centro de Estudios Clinicos y Especialidades Medicas S.C.
state: Nuevo Leon
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Moscow
country: Russian Federation
facility: FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
city: Moscow
country: Russian Federation
facility: FSBI Moscow Scientific Research Institute of Psychiatry"
city: Moscow
country: Russian Federation
facility: Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
city: Moscow
country: Russian Federation
facility: Clinical Mental Hospital #12 of Moscow Healthcare Department
city: Nizhni Novgorod
country: Russian Federation
facility: Clinical Psychiatric Hospital #1 of Nizhni Novgorod
city: Saint-Petersburg
country: Russian Federation
facility: FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
city: Smolensk
country: Russian Federation
facility: SBEI HPE ##Smolensk State Medical Academy## of MoH of RF
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
city: St. Petersburg
country: Russian Federation
facility: State Healthcare Institution "Psychoneurological Dispensary #2
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia, Mentum, s.r.o.
city: Bratislava
country: Slovakia
facility: Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
city: Levice
country: Slovakia
facility: Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Psychiatricka ambulancia, PsychoLine s.r.o.
city: Roznava
country: Slovakia
facility: Nemocnica s poliklinikou sv. Barbory Roznava a.s.
city: Bellville
country: South Africa
facility: Flexivest Fourteen Research Center
state: Cape Town
city: Benoni, Johannesburg
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Centurion
country: South Africa
facility: Vista Clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trials Centre
state: Gauteng
city: Lyttelton
country: South Africa
facility: I Engelbrecht Research Pty, Ltd
state: Gauteng
city: Midrand
country: South Africa
facility: Midrand Medical Centre
state: Gauteng
city: Durban
country: South Africa
facility: Private Practice
state: Kwa-Zulu Natal
city: Durban
country: South Africa
facility: Randles Road Medical Centre
state: Kwazulu Natal
city: Cape Town
country: South Africa
facility: Dr John OBrien Incorporated
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Unidad Especializada en Tabaquismo de la Comunidad de Madrid
city: Zaragoza
country: Spain
facility: Centro de Salud Torrero La Paz
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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citation: Beard E, Jackson SE, Anthenelli RM, Benowitz NL, Aubin LS, McRae T, Lawrence D, Russ C, Krishen A, Evins AE, West R. Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors. Addiction. 2021 Oct;116(10):2816-2824. doi: 10.1111/add.15440. Epub 2021 Apr 22.
citation: Correa JB, Lawrence D, McKenna BS, Gaznick N, Saccone PA, Dubrava S, Doran N, Anthenelli RM. Psychiatric Comorbidity and Multimorbidity in the EAGLES Trial: Descriptive Correlates and Associations With Neuropsychiatric Adverse Events, Treatment Adherence, and Smoking Cessation. Nicotine Tob Res. 2021 Aug 29;23(10):1646-1655. doi: 10.1093/ntr/ntab056.
citation: Nollen NL, Ahluwalia JS, Sanderson Cox L, Okuyemi K, Lawrence D, Samuels L, Benowitz NL. Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation: Secondary Analysis of the EAGLES Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032053. doi: 10.1001/jamanetworkopen.2020.32053.
citation: Evins AE, West R, Benowitz NL, Russ C, Lawrence D, McRae T, Maravic MC, Heffner JL, Anthenelli RM. Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES. Psychiatr Serv. 2021 Jan 1;72(1):7-15. doi: 10.1176/appi.ps.202000032. Epub 2020 Nov 3.
citation: Ayers CR, Heffner JL, Russ C, Lawrence D, McRae T, Evins AE, Anthenelli RM. Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active- and placebo-controlled EAGLES trial. Depress Anxiety. 2020 Mar;37(3):247-260. doi: 10.1002/da.22982. Epub 2019 Dec 18.
citation: Heffner JL, Evins AE, Russ C, Lawrence D, Ayers CR, McRae T, Aubin LS, Krishen A, West R, Anthenelli RM. Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: Subgroup analysis of a randomized clinical trial. J Affect Disord. 2019 Sep 1;256:267-277. doi: 10.1016/j.jad.2019.06.008. Epub 2019 Jun 3.
citation: Anthenelli RM, Gaffney M, Benowitz NL, West R, McRae T, Russ C, Lawrence D, St Aubin L, Krishen A, Evins AE. Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial. J Gen Intern Med. 2019 Jun;34(6):862-870. doi: 10.1007/s11606-019-04858-2. Epub 2019 Mar 7.
citation: West R, Evins AE, Benowitz NL, Russ C, McRae T, Lawrence D, St Aubin L, Krishen A, Maravic MC, Anthenelli RM. Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES. Addiction. 2018 Aug;113(8):1507-1516. doi: 10.1111/add.14208. Epub 2018 Mar 30.
citation: Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22.