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

Smoking Cessation Clinical Trial

— EAGLES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456936
• Other study ID #: A3051123
• Secondary ID: 2010-022914-15EA
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2011
• Last updated: October 12, 2015
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8133
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Smoking Cessation

Intervention

Drug:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  Denmark,  Finland,  Germany,  Mexico,  New Zealand,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 1 severe AE of anxiety depression, feeling abnormal, or hostility and/or moderate or severe AE of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation/behavior/completed		Week 12	Yes
Primary	4 week Carbon Monoxide (CO) confirmed continuous abstinence for Weeks 9 through 12.		Week 12	No
Secondary	Carbon Monoxide (CO) confirmed continuous abstinence from Week 9 through Week 24		Week 24	No
Secondary	The presence or absence of each component comprising the primary neuropsychiatric adverse event endpoint.		Week 12	Yes
Secondary	Individual item responses and overall scores for Hospital Anxiety and Depression Scale		12 weeks	Yes
Secondary	Individual item responses and overall scores for Columbia Suicide Severity Rating Scale		12 weeks	Yes
Secondary	Individual item responses and overall scores for Global Clinical Impression of Improvement		12 weeks	Yes

External Links

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