Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
EAGLES
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
3 other identifiers
interventional
8,144
16 countries
156
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2011
Typical duration for phase_4
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
May 2, 2016
CompletedJune 10, 2016
May 1, 2016
3.2 years
October 14, 2011
January 12, 2016
May 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Estimated NPS AE Rate (%), by Cohort
The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary Outcomes (23)
Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Occurrence of the Components of NPS AE Primary Endpoint (Overall)
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
- +18 more secondary outcomes
Study Arms (4)
placebo
PLACEBO COMPARATORSubjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive.
varenicline
ACTIVE COMPARATORbupropion
ACTIVE COMPARATORNicotine Replacement Therapy Patch
ACTIVE COMPARATORInterventions
Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks
Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).
Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- GlaxoSmithKlinecollaborator
Study Sites (156)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
NoesisPharma Research
Phoenix, Arizona, 85032, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Synergy Clinical Research of Escondido
Escondido, California, 92025, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Omega Clinical Trials
La Habra, California, 90631, United States
Pacific Treatment and Research Center UC San Diego Health System
La Jolla, California, 92037, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, 90095, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
North County Clinical Research
Oceanside, California, 92056, United States
Neuropsychiatric Research Center of Orange County
Orange, California, 92868, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program
Aurora, Colorado, 80045, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Broward Research Group
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Clinical Neuroscience Solutions,Inc.
Jacksonville, Florida, 32256, United States
Meridien Research
Lakeland, Florida, 33805, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Ocala Psychiatric Associates
Ocala, Florida, 34474, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Meridien Research
Tampa, Florida, 33634, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Northwest Neurobehavioral Health
Meridian, Idaho, 83642, United States
AMR-Baber Research Inc.
Naperville, Illinois, 60563, United States
American Health Network of IN, LLC
Indianaopolis, Indiana, 46254, United States
Davis Clinic, Incorporated
Indianapolis, Indiana, 46250, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Kentucky Research Group
Louisville, Kentucky, 40218, United States
A Professional Corporation dba The Center for Sexual Health
Metairie, Louisiana, 70002, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Community Clinical Services
Lewiston, Maine, 04240, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Milford Emergency Associates, Incorporated
Milford, Massachusetts, 01757, United States
Rahim Shafa, MD
Milford, Massachusetts, 01757, United States
University of Minnesota- TC
Minneapolis, Minnesota, 55414, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building
Princeton, New Jersey, 08540, United States
Social Psychiatry Research Institute Clinical Trials LLC
Brooklyn, New York, 11235, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Tooley Group
Cary, North Carolina, 27511, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, 27612, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Oregon Health and Sciences University
Portland, Oregon, 97239-3098, United States
Southeastern PA Medical Institute
Broomall, Pennsylvania, 19008, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
East Side Clinical Laboratory
Lincoln, Rhode Island, 02865, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Clinical NeuroScience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
James G. Kyser, MD
Nashville, Tennessee, 37203, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77230-1439, United States
Peninsula Psychotherapy Center, LLC
Newport News, Virginia, 23606, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53711-2027, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Centro Medico Dra. De Salvo
Ciudad Autonoma de Bs. As, Buenos Aires, C1426ABP, Argentina
Centro de Investigacion Clinica WM
Mataderos, Buenos Aires, C1440BRR, Argentina
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004, Australia
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, 60846-190, Brazil
Irmandade da Santa Casa de Misericórdia Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
Campinas, São Paulo, 13059-740, Brazil
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
São Paulo, São Paulo, 05017-000, Brazil
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
Burgas, 8000, Bulgaria
MBAL Dr. Hristo Stambolski EOOD
Kazanlak, 6100, Bulgaria
DPB Sv. Ivan Rilski
Novi Iskar, 1282, Bulgaria
UMBAL Dr. Georgi Stranski EAD,
Pleven, 5800, Bulgaria
UMBAL Sveti Georgi EAD, Klinika po psihiatriya
Plovdiv, 4002, Bulgaria
SBALPFZ - Ruse EOOD
Rousse, 7002, Bulgaria
Tsentar za psihichno zdrave - Ruse EOOD
Rousse, 7004, Bulgaria
Meditsinski Tsentar ¿Sveti Naum¿ EOOD
Sofia, 1113, Bulgaria
MHATNP Sveti Naum SJsc.
Sofia, 1113, Bulgaria
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,
Troyan Municipality, 5600, Bulgaria
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7, Canada
Medical Research Associates
Mississauga, Ontario, L5M 4N4, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 2C5, Canada
Dr. Felix Yaroshevsky
Toronto, Ontario, M4W 3C7, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M5S 2S1, Canada
Centre of Addiction and Mental Health Pharmacy
Toronto, Ontario, M6J 1H4, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
Talca, Maule Region, 3460001, Chile
Centro Respiratorio Integral (CENRESIN Ltda.)
Quillota, Valparaiso, V Region, 2260877, Chile
CCBR A/S
Ballerup Municipality, 2750, Denmark
CCBR A/S
Vejle, 7100, Denmark
Mehiläinen Leppävaara
Espoo, 02600, Finland
Savon Psykiatripalvelu Oy
Kuopio, 70110, Finland
Mehiläinen Nummela
Nummela, 03100, Finland
Oulu Mentalcare
Oulu, 90100, Finland
Porin Lääkäritalo Oy
Pori, 28100, Finland
PEL, Psykiatrian ErikoiLääkärit
Turku, 20100, Finland
Klinische Forschung Hamburg GmbH
Hamburg, Hamburg, 20253, Germany
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
Leipzig, Saxony, 04157, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, State of Berlin, 10117, Germany
emovis GmbH
Berlin, State of Berlin, 10629, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79104, Germany
Ludwig Maximilians-Universitaet Muenchen
München, 80336, Germany
Universitaetsklinik Tuebingen
Tübingen, 72076, Germany
Centro Respiratorio de Mexico S.C.
México, D.f., 14050, Mexico
Consultarios de Medicina Especializada del Sector Privado
Colonia Hipodromo Condesa, Mexico DF, 06100, Mexico
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
Morelia, Michoacán, 58249, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo León, 64620, Mexico
Lakeland Clinical Trials
Rotorua, 3010, New Zealand
FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
Moscow, 107076, Russia
FSBI Moscow Scientific Research Institute of Psychiatry"
Moscow, 107076, Russia
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
Moscow, 117152, Russia
Clinical Mental Hospital #12 of Moscow Healthcare Department
Moscow, 125367, Russia
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
Nizhny Novgorod, 603155, Russia
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
Saint Petersburg, 190121, Russia
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
Saint Petersburg, 192019, Russia
State Healthcare Institution "Psychoneurological Dispensary #2
Saint Petersburg, 197341, Russia
SBEI HPE ##Smolensk State Medical Academy## of MoH of RF
Smolensk, 214019, Russia
Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation
Smolensk, 214019, Russia
Psychiatricka ambulancia, Mentum, s.r.o.
Bratislava, 82007, Slovakia
Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
Bratislava, 851 01, Slovakia
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
Levice, 93401, Slovakia
Psychiatricka ambulancia, PsychoLine s.r.o.
Rimavská Sobota, 979 01, Slovakia
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
Rožňava, 04801, Slovakia
Flexivest Fourteen Research Center
Bellville, Cape Town, 7530, South Africa
Worthwhile Clinical Trials
Benoni, Johannesburg, Gauteng, 1500, South Africa
Vista Clinic
Centurion, Gauteng, 0157, South Africa
Soweto Clinical Trials Centre
Johannesburg, Gauteng, 1818, South Africa
I Engelbrecht Research Pty, Ltd
Lyttelton, Gauteng, 0157, South Africa
Midrand Medical Centre
Midrand, Gauteng, 1685, South Africa
Private Practice
Durban, KwaZulu-Natal, 4091, South Africa
Randles Road Medical Centre
Durban, KwaZulu-Natal, 4091, South Africa
Dr John OBrien Incorporated
Cape Town, Western Cape, 8001, South Africa
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital General Universitari Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Clinic I Provincial
Barcelona, Barcelona, 08036, Spain
Hospital San Pedro de Alcantara
Cáceres, Caceres, 10003, Spain
Unidad Especializada en Tabaquismo de la Comunidad de Madrid
Madrid, Madrid, 28015, Spain
Centro de Salud Torrero La Paz
Zaragoza, Zaragoza, 50007, Spain
Related Publications (14)
Daniel B, Lawrence DE, McKenna BS, Saccone P, McRae T, Evins AE, Anthenelli RM. Do tobacco regulatory and economic factors influence smoking cessation outcomes? A post-hoc analysis of the multinational EAGLES randomised controlled trial. BMJ Open. 2024 Sep 20;14(9):e079092. doi: 10.1136/bmjopen-2023-079092.
PMID: 39306350DERIVEDTonnesen P, Lawrence D, Tonstad S. Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial. Tob Induc Dis. 2022 May 10;20:46. doi: 10.18332/tid/146567. eCollection 2022.
PMID: 35611069DERIVEDCinciripini PM, Kypriotakis G, Green C, Lawrence D, Anthenelli RM, Minnix J, Blalock JA, Beneventi D, Morris C, Karam-Hage M. The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial. Depress Anxiety. 2022 May;39(5):429-440. doi: 10.1002/da.23259.
PMID: 35535436DERIVEDEbbert JO, Jimenez-Ruiz C, Dutro MP, Fisher M, Li J, Hays JT. In Reply: Changing the Culture of Tobacco Dependence Treatment Among Not Only Patients, But Also Prescribers. Mayo Clin Proc. 2021 Sep;96(9):2495. doi: 10.1016/j.mayocp.2021.07.010. No abstract available.
PMID: 34481605DERIVEDEbbert J, Jimenez-Ruiz C, Dutro MP, Fisher M, Li J, Hays JT. Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Mayo Clin Proc. 2021 Jul;96(7):1801-1811. doi: 10.1016/j.mayocp.2020.10.046. Epub 2021 Jun 8.
PMID: 34112520DERIVEDBeard 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.
PMID: 33885203DERIVEDCorrea 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.
PMID: 33788933DERIVEDNollen 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.
PMID: 33464316DERIVEDEvins 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.
PMID: 33138708DERIVEDAyers 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.
PMID: 31850603DERIVEDHeffner 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.
PMID: 31195244DERIVEDAnthenelli 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.
PMID: 30847828DERIVEDWest 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.
PMID: 29508470DERIVEDAnthenelli 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.
PMID: 27116918DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
After database lock and unblinding, one additional participant in the NRT arm of psychiatric cohort was found who had a primary endpoint event (moderate suicidal ideation) which required hospitalization; this event is not included in any analyses.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2011
First Posted
October 21, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 10, 2016
Results First Posted
May 2, 2016
Record last verified: 2016-05