8,144
Participants
Start Date
November 30, 2011
Primary Completion Date
January 31, 2015
Study Completion Date
January 31, 2015
Placebo
Triple dummy placebo for each treatment arm
varenicline tartrate
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 hydrochloride
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 Patch
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.
Meditsinski Tsentar ¿Sveti Naum¿ EOOD, Sofia
MHATNP Sveti Naum SJsc., Sofia
DPB Sv. Ivan Rilski, Novi Iskar
Worthwhile Clinical Trials, Benoni, Johannesburg
Midrand Medical Centre, Midrand
Soweto Clinical Trials Centre, Johannesburg
CCBR A/S, Ballerup Municipality
Monash Alfred Psychiatry Research Centre, Melbourne
Lakeland Clinical Trials, Rotorua
UMBAL Sveti Georgi EAD, Klinika po psihiatriya, Plovdiv
Royal Brisbane & Women's Hospital, Herston
Private Practice, Durban
Randles Road Medical Centre, Durban
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,, Troyan Municipality
UMBAL Dr. Georgi Stranski EAD,, Pleven
MBAL Dr. Hristo Stambolski EOOD, Kazanlak
SBALPFZ - Ruse EOOD, Rousse
Tsentar za psihichno zdrave - Ruse EOOD, Rousse
CCBR A/S, Vejle
Flexivest Fourteen Research Center, Bellville
"Mental Health Center Prof. Dr. Ivan Temkov-Bourgas Ltd.", Burgas
Dr John OBrien Incorporated, Cape Town
Hospital San Pedro de Alcantara, Cáceres
Klinische Forschung Berlin-Mitte GmbH, Berlin
emovis GmbH, Berlin
Social Psychiatry Research Institute Clinical Trials LLC, Brooklyn
Regional Clinical Research, Inc., Endwell
Centro Respiratorio de Mexico S.C., México
Southeastern PA Medical Institute, Broomall
Belmont Center for Comprehensive Treatment, Philadelphia
CRI Worldwide, LLC, Philadelphia
PEL, Psykiatrian ErikoiLääkärit, Turku
Klinische Forschung Hamburg GmbH, Hamburg
Clinical Research Associates of Tidewater, Norfolk
Peninsula Psychotherapy Center, LLC, Newport News
Tooley Group, Cary
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary
Wake Internal Medicine Consultants, Inc, Raleigh
Wake Research Associates, LLC, Raleigh
Unidad Especializada en Tabaquismo de la Comunidad de Madrid, Madrid
Porin Lääkäritalo Oy, Pori
Coastal Carolina Research Center, Mt. Pleasant
Northwest Behavioral Research Center, Marietta
Clinical Research Atlanta, Stockbridge
Jacksonville Center for Clinical Research, Jacksonville
Mayo Clinic, Jacksonville
Clinical Neuroscience Solutions,Inc., Jacksonville
Clinical Neuroscience Solutions, Inc, Orlando
Broward Research Group, Hollywood
Meridien Research, Tampa
Meridien Research, Lakeland
Neuropsychiatric Research Center of Southwest Florida, Fort Myers
Renstar Medical Research, Ocala
Ocala Psychiatric Associates, Ocala
Coastal Clinical Research, Inc., Mobile
Clinical Research Associates, Inc., Nashville
James G. Kyser, MD, Nashville
New Orleans Center for Clinical Research, Knoxville
Volunteer Research Group, Knoxville
Clinical NeuroScience Solutions, Inc., Memphis
Precise Research Centers, Flowood
Kentucky Research Group, Louisville
Central Kentucky Research Associates, Inc., Lexington
Midwest Clinical Research Center, Dayton
Davis Clinic, Incorporated, Indianapolis
American Health Network of IN, LLC, Indianaopolis
Goldpoint Clinical Research, LLC, Indianapolis
Centro de Salud Torrero La Paz, Zaragoza
University of Wisconsin Hospital and Clinics, Madison
University of Minnesota- TC, Minneapolis
Mayo Clinic, Rochester
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C., Morelia
AMR-Baber Research Inc., Naperville
Mercy Health Research, St Louis
The Center for Pharmaceutical Research, PC, Kansas City
Centro de Estudios Clinicos y Especialidades Medicas S.C., Monterrey
Vince and Associates Clinical Research, Overland Park
Heartland Research Associates, LLC, Wichita
A Professional Corporation dba The Center for Sexual Health, Metairie
Savon Psykiatripalvelu Oy, Kuopio
Universitaetsklinik Tuebingen, Tübingen
InSite Clinical Research, DeSoto
FutureSearch Clinical Trials, L.P., Austin
Universitaetsklinikum Freiburg, Freiburg im Breisgau
University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program, Aurora
Western Affiliated Research Institute, Denver
Ludwig Maximilians-Universitaet Muenchen, München
Psychiatricka ambulancia, Mentum, s.r.o., Bratislava
Advanced Clinical Research, Meridian
Northwest Neurobehavioral Health, Meridian
NoesisPharma Research, Phoenix
David Geffen School of Medicine at University of California, Los Angeles, Los Angeles
Oulu Mentalcare, Oulu
Omega Clinical Trials, La Habra
Pharmacology Research Institute, Los Alamitos
Pharmacology Research Institute, Encino
California Neuroscience Research Medical Group, Inc., Sherman Oaks
Synergy Clinical Research of Escondido, Escondido
Pacific Treatment and Research Center UC San Diego Health System, La Jolla
North County Clinical Research, Oceanside
Sun Valley Research Center, Imperial
Pharmacology Research Institute, Newport Beach
Neuropsychiatric Research Center of Orange County, Orange
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o., Levice
"FSBI Federal Medical Research Center of Psychiatry and Addiction Medicine", Moscow
"FSBI Moscow Scientific Research Institute of Psychiatry", Moscow
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva, Moscow
Clinical Mental Hospital #12 of Moscow Healthcare Department, Moscow
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital, Saint Petersburg
"FSBI Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev of MoH", Saint Petersburg
"State Healthcare Institution Psychoneurological Dispensary #2", Saint Petersburg
SBEI HPE ##Smolensk State Medical Academy## of MoH of RF, Smolensk
Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation, Smolensk
Clinical Psychiatric Hospital #1 of Nizhni Novgorod, Nizhny Novgorod
Centro Respiratorio Integral (CENRESIN Ltda.), Quillota
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias, Talca
Comprehensive Psychiatric Care, Norwich
Maine Research Associates, Auburn
Community Clinical Services, Lewiston
Massachusetts General Hospital, Boston
Milford Emergency Associates, Incorporated, Milford
Rahim Shafa, MD, Milford
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick
Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building, Princeton
Oregon Health and Sciences University, Portland
East Side Clinical Laboratory, Lincoln
Lincoln Research, Lincoln
The University of Texas M.D. Anderson Cancer Center, Houston
University of Wisconsin School of Medicine and Public Health, Madison
Centro Medico Dra. De Salvo, Ciudad Autonoma de Bs. As
Centro de Investigacion Clinica WM, Mataderos
Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza
Irmandade da Santa Casa de Misericórdia Porto Alegre, Porto Alegre
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia, Porto Alegre
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II, Campinas
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda, São Paulo
Hamilton Medical Research Group, Hamilton
Medical Research Associates, Mississauga
University of Ottawa Heart Institute, Ottawa
Canadian Phase Onward Inc., Toronto
Dr. Felix Yaroshevsky, Toronto
Centre for Addiction and Mental Health (CAMH), Toronto
Centre of Addiction and Mental Health Pharmacy, Toronto
Diex Research Sherbrooke Inc., Sherbrooke
Mehiläinen Leppävaara, Espoo
Mehiläinen Nummela, Nummela
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH, Leipzig
Consultarios de Medicina Especializada del Sector Privado, Colonia Hipodromo Condesa
Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD, Bratislava
Psychiatricka ambulancia, PsychoLine s.r.o., Rimavská Sobota
Nemocnica s poliklinikou sv. Barbory Roznava a.s., Rožňava
Vista Clinic, Centurion
I Engelbrecht Research Pty, Ltd, Lyttelton
Hospital de La Santa Creu I Sant Pau, Barcelona
Hospital General Universitari Vall d'Hebron, Barcelona
Hospital Clinic I Provincial, Barcelona
Lead Sponsor
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Pfizer
INDUSTRY