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Smoking CessationPhase 4EAGLESNCT01456936

Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

A Phase 4 study testing varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch in people with Smoking Cessation, run by Pfizer at 156 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,144 participants
Where
156 sitesin 16 countries
Study dates
Nov 2011to Jan 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

156 sites in 16 countries.

156 sites in 16 countries

United States77 sites

  • Maine Research Associates

    Auburn, Maine, 04210

  • University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program

    Aurora, Colorado, 80045

  • FutureSearch Clinical Trials, L.P.

    Austin, Texas, 78731

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Social Psychiatry Research Institute Clinical Trials LLC

    Brooklyn, New York, 11235

  • Southeastern PA Medical Institute

    Broomall, Pennsylvania, 19008

  • Tooley Group

    Cary, North Carolina, 27511

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina, 27518

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Western Affiliated Research Institute

    Denver, Colorado, 80209

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Synergy Clinical Research of Escondido

    Escondido, California, 92025

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Broward Research Group

    Hollywood, Florida, 33024

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77230-1439

  • Sun Valley Research Center

    Imperial, California, 92251

  • American Health Network of IN, LLC

    Indianaopolis, Indiana, 46254

  • Davis Clinic, Incorporated

    Indianapolis, Indiana, 46250

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Clinical Neuroscience Solutions,Inc.

    Jacksonville, Florida, 32256

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Omega Clinical Trials

    La Habra, California, 90631

  • Pacific Treatment and Research Center UC San Diego Health System

    La Jolla, California, 92037

  • Meridien Research

    Lakeland, Florida, 33805

  • Community Clinical Services

    Lewiston, Maine, 04240

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • East Side Clinical Laboratory

    Lincoln, Rhode Island, 02865

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • David Geffen School of Medicine at University of California, Los Angeles

    Los Angeles, California, 90095

  • Kentucky Research Group

    Louisville, Kentucky, 40218

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53711-2027

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • Clinical NeuroScience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Northwest Neurobehavioral Health

    Meridian, Idaho, 83642

  • A Professional Corporation dba The Center for Sexual Health

    Metairie, Louisiana, 70002

  • Milford Emergency Associates, Incorporated

    Milford, Massachusetts, 01757

  • Rahim Shafa, MD

    Milford, Massachusetts, 01757

  • University of Minnesota- TC

    Minneapolis, Minnesota, 55414

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • AMR-Baber Research Inc.

    Naperville, Illinois, 60563

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • James G. Kyser, MD

    Nashville, Tennessee, 37203

  • University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Peninsula Psychotherapy Center, LLC

    Newport News, Virginia, 23606

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Ocala Psychiatric Associates

    Ocala, Florida, 34474

  • North County Clinical Research

    Oceanside, California, 92056

  • Neuropsychiatric Research Center of Orange County

    Orange, California, 92868

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 66212

  • Belmont Center for Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania, 19139

  • NoesisPharma Research

    Phoenix, Arizona, 85032

  • Oregon Health and Sciences University

    Portland, Oregon, 97239-3098

  • Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building

    Princeton, New Jersey, 08540

  • Wake Internal Medicine Consultants, Inc

    Raleigh, North Carolina, 27612

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33634

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Bulgaria10 sites

  • Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.

    Burgas, 8000

  • MBAL Dr. Hristo Stambolski EOOD

    Kazanlak, 6100

  • DPB Sv. Ivan Rilski

    Novi Iskar, 1282

  • UMBAL Dr. Georgi Stranski EAD,

    Pleven, 5800

  • UMBAL Sveti Georgi EAD, Klinika po psihiatriya

    Plovdiv, 4002

  • SBALPFZ - Ruse EOOD

    Rousse, 7002

  • Tsentar za psihichno zdrave - Ruse EOOD

    Rousse, 7004

  • Meditsinski Tsentar ¿Sveti Naum¿ EOOD

    Sofia, 1113

  • MHATNP Sveti Naum SJsc.

    Sofia, 1113

  • Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,

    Troyan Municipality, 5600

Other trials in Bulgaria

Russia10 sites

  • FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"

    Moscow, 107076

  • FSBI Moscow Scientific Research Institute of Psychiatry"

    Moscow, 107076

  • Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva

    Moscow, 117152

  • Clinical Mental Hospital #12 of Moscow Healthcare Department

    Moscow, 125367

  • Clinical Psychiatric Hospital #1 of Nizhni Novgorod

    Nizhny Novgorod, 603155

  • St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital

    Saint Petersburg, 190121

  • FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH

    Saint Petersburg, 192019

  • State Healthcare Institution "Psychoneurological Dispensary #2

    Saint Petersburg, 197341

  • SBEI HPE ##Smolensk State Medical Academy## of MoH of RF

    Smolensk, 214019

  • Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation

    Smolensk, 214019

Other trials in Russia

South Africa9 sites

  • Flexivest Fourteen Research Center

    Bellville, Cape Town, 7530

  • Worthwhile Clinical Trials

    Benoni, Johannesburg, Gauteng, 1500

  • Dr John OBrien Incorporated

    Cape Town, Western Cape, 8001

  • Vista Clinic

    Centurion, Gauteng, 0157

  • Private Practice

    Durban, KwaZulu-Natal, 4091

  • Randles Road Medical Centre

    Durban, KwaZulu-Natal, 4091

  • Soweto Clinical Trials Centre

    Johannesburg, Gauteng, 1818

  • I Engelbrecht Research Pty, Ltd

    Lyttelton, Gauteng, 0157

  • Midrand Medical Centre

    Midrand, Gauteng, 1685

Other trials in South Africa

Canada8 sites

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • Medical Research Associates

    Mississauga, Ontario, L5M 4N4

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 2C5

  • Dr. Felix Yaroshevsky

    Toronto, Ontario, M4W 3C7

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M5S 2S1

  • Centre of Addiction and Mental Health Pharmacy

    Toronto, Ontario, M6J 1H4

Other trials in Canada

Germany7 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, State of Berlin, 10117

  • emovis GmbH

    Berlin, State of Berlin, 10629

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79104

  • Klinische Forschung Hamburg GmbH

    Hamburg, Free and Hanseatic City of Hamburg, 20253

  • ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH

    Leipzig, Saxony, 04157

  • Ludwig Maximilians-Universitaet Muenchen

    München, 80336

  • Universitaetsklinik Tuebingen

    Tübingen, 72076

Other trials in Germany

Finland6 sites

  • Mehiläinen Leppävaara

    Espoo, 02600

  • Savon Psykiatripalvelu Oy

    Kuopio, 70110

  • Mehiläinen Nummela

    Nummela, 03100

  • Oulu Mentalcare

    Oulu, 90100

  • Porin Lääkäritalo Oy

    Pori, 28100

  • PEL, Psykiatrian ErikoiLääkärit

    Turku, 20100

Other trials in Finland

Spain6 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital General Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, Barcelona, 08036

  • Hospital San Pedro de Alcantara

    Cáceres, Caceres, 10003

  • Unidad Especializada en Tabaquismo de la Comunidad de Madrid

    Madrid, Madrid, 28015

  • Centro de Salud Torrero La Paz

    Zaragoza, Zaragoza, 50007

Other trials in Spain

Brazil5 sites

  • Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II

    Campinas, São Paulo, 13059-740

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, Ceará, 60846-190

  • Irmandade da Santa Casa de Misericórdia Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda

    São Paulo, São Paulo, 05017-000

Other trials in Brazil

Slovakia5 sites

  • Psychiatricka ambulancia, Mentum, s.r.o.

    Bratislava, 82007

  • Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD

    Bratislava, 851 01

  • Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.

    Levice, 93401

  • Psychiatricka ambulancia, PsychoLine s.r.o.

    Rimavská Sobota, 979 01

  • Nemocnica s poliklinikou sv. Barbory Roznava a.s.

    Rožňava, 04801

Other trials in Slovakia

Mexico4 sites

  • Consultarios de Medicina Especializada del Sector Privado

    Colonia Hipodromo Condesa, Mexico DF, 06100

  • Centro Respiratorio de Mexico S.C.

    México, D.f., 14050

  • Centro de Estudios Clinicos y Especialidades Medicas S.C.

    Monterrey, Nuevo León, 64620

  • Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.

    Morelia, Michoacán, 58249

Other trials in Mexico

Argentina2 sites

  • Centro Medico Dra. De Salvo

    Ciudad Autonoma de Bs. As, Buenos Aires, C1426ABP

  • Centro de Investigacion Clinica WM

    Mataderos, Buenos Aires, C1440BRR

Other trials in Argentina

Australia2 sites

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

Other trials in Australia

Chile2 sites

  • Centro Respiratorio Integral (CENRESIN Ltda.)

    Quillota, Valparaiso, V Region, 2260877

  • Hospital Regional de Talca, Unidad de Enfermedades Respiratorias

    Talca, Maule Region, 3460001

Other trials in Chile

Denmark2 sites

  • CCBR A/S

    Ballerup Municipality, 2750

  • CCBR A/S

    Vejle, 7100

Other trials in Denmark

New Zealand1 site

  • Lakeland Clinical Trials

    Rotorua, 3010

Other trials in New Zealand

About this study

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

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).

Being tested
Placebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
Keywords
smoking cessation, psychiatric disease
Medical subject headings
Smoking Cessation, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Triple dummy placebo for each treatment arm

  • varenicline tartrateDrug

    Also called Chantix; Champix

    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

  • bupropion hydrochlorideDrug

    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).

  • Nicotine Replacement Therapy PatchDrug

    Also called NRT

    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.

Study groups in NCT01456936
Study groupRoleWhat they receive
placeboPlacebo 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.
Receives: Drug: Placebo
vareniclineActive comparatorNot described
Receives: Drug: varenicline tartrate
bupropionActive comparatorNot described
Receives: Drug: bupropion hydrochloride
Nicotine Replacement Therapy PatchActive comparatorNot described
Receives: Drug: Nicotine Replacement Therapy Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  2. 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.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

Secondary outcomes (23)

  1. Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort

    The 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. Each of these 16 components is reported below.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  2. Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort

    The 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. Each of these 16 components is reported below.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  3. Occurrence of the Components of NPS AE Primary Endpoint (Overall)

    The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  4. Occurrence of Severe-only NPS AEs in the Primary Endpoint, 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. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  5. Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort

    The 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. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  6. Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort

    The 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. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  7. Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)

    The NPS AE endpoint was the occurrence of at least 1 treatment-emergent "severe" AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent "severe" AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

    Measured: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  8. Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort

    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

    Measured: Baseline to Week 24

  9. HADS Total Score, Psychiatric History Cohort

    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

    Measured: Baseline to Week 24

  10. HADS Total Score (Overall)

    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

    Measured: Baseline to Week 24

  11. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort

    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides.

    Measured: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  12. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort

    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.

    Measured: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  13. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall

    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.

    Measured: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.

  14. Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit

    The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as "normal, not at all ill" on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as "no change" on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs.

    Measured: Baseline to Week 24

  15. CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

    Measured: Week 9 through Week 12

  16. CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

    Measured: Week 9 through Week 12

  17. CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

    Measured: Week 9 through Week 12

  18. CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

    Measured: Week 9 through Week 24

  19. CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

    Measured: Week 9 through Week 24

  20. CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)

    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

    Measured: Week 9 through Week 24

  21. 7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?

    Measured: 24 Weeks

  22. 7-Day Point Prevalence of Abstinence, Psychiatric History Cohort

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?

    Measured: 24 Weeks

  23. 7-Day Point Prevalence of Abstinence (Overall)

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8,144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456936
Sponsor's protocol ID
A3051123
Other IDs
2010-022914-15, EAGLES
Acronym
EAGLES
Status last verified
May 2016
First submitted
14 Oct 2011
Last updated
10 Jun 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39306350

  • Tonnesen 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.

    PubMed 35611069

  • Cinciripini 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.

    PubMed 35535436

  • Ebbert 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.

    PubMed 34481605

  • Ebbert 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.

    PubMed 34112520

  • 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.

    PubMed 33885203

  • 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.

    PubMed 33788933

  • 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.

    PubMed 33464316

  • 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.

    PubMed 33138708

  • 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.

    PubMed 31850603

  • 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.

    PubMed 31195244

  • 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.

    PubMed 30847828

  • 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.

    PubMed 29508470

  • 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.

    PubMed 27116918

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch in people with Smoking Cessation, run by Pfizer at 156 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Bulgaria, Russia, South Africa, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (time frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01456936, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.

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