Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
NCT ID: NCT01078298
Last Updated: 2013-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
525 participants
INTERVENTIONAL
2010-03-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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varenicline
varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
placebo
placebo
placebo
placebo tablets matched in appearance and dosage to varenicline tablets
Interventions
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varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
placebo
placebo tablets matched in appearance and dosage to varenicline tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) \> 10 ppm at screening
* Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
* On stable antidepressant treatment for MDD (stable dose for at least 2 months)
* Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
Exclusion Criteria
* Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
* Current use of either bupropion or nortryptiline.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States
Behavioral Health and Wellness Program, University of Colorado Denver
Aurora, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Emerald Coast Mood & Memory, PA
Fort Walton Beach, Florida, United States
Clinical Neuroscience Solutions Incorporated
Jacksonville, Florida, United States
Clinical Neuroscience Solutions Incorporated
Orlando, Florida, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
NorthCoast Clinical Trials Inc.
Beachwood, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
CRI Worldwide LLC
Philadelphia, Pennsylvania, United States
Clinical Trials of Memphis
Bartlett, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States
Psychiatric Clinic, Clinical Center Banja Luka
Banja Luka, , Bosnia and Herzegovina
Clinic of Psychiatry, Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
"Poliklinika Neuron" - Croatian Institute for Brain Research
Zagreb, , Croatia
Psychiatric Hospital Vrapce
Zagreb, , Croatia
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Ludwig Maximilians-Universitaet Muenchen
München, , Germany
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
Tübingen, , Germany
Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
Budapest, , Hungary
Processus Kft., Varoskapu Rendelo
Budapest, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
Gyula, , Hungary
Varosi Egeszsegugyi Kozpont
Kunszentmárton, , Hungary
Donatella 99 Bt.
Szentes, , Hungary
Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
Székesfehérvár, , Hungary
Spitalul Clinic de Psihiatrie Socola, sectia VII
Iași, Iaşi, Romania
Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
Bucharest, Sector 4, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
Bucharest, , Romania
Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
Moscow, , Russia
Institution of Russian Academy of Medical Sciences Mental Health Research Center
Moscow, , Russia
Moscow State Healthcare Institution Clinical Mental Hospital No 12
Moscow, , Russia
St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
Saint Petersburg, , Russia
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
Hospital General de La Vall D'Hebron
Barcelona, Barcelona, Spain
Centro de Salud Mental Ii "La Corredoria"
Oviedo, Principality of Asturias, Spain
Centro de Salud Torrero La Paz
Zaragoza, Zaragoza, Spain
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.
Related Links
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Other Identifiers
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A3051122
Identifier Type: -
Identifier Source: org_study_id
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