Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
312 participants
INTERVENTIONAL
2011-04-30
2018-01-31
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
QUADRUPLE
Study Groups
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Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Interventions
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Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Eligibility Criteria
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Inclusion Criteria
* Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
* Subjects must have at least one prior failed attempt to quit smoking.
Exclusion Criteria
* Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
* Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.
12 Years
19 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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IICR, Inc. (DBA: International Institute of Clinical Research)
Ozark, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Omega Clinical Trials, LLC
La Habra, California, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
North County Clinical Research
Oceanside, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Connecticut Mental Health Center
New Haven, Connecticut, United States
Yale University, SATU
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Hope Clinical Research
Kissimmee, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
L & L Research Choices
Miami, Florida, United States
Bravo Health Care Center
North Bay Village, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Comprehensive Clinical Development Inc.
St. Petersburg, Florida, United States
Barney Greenspan, Ph.D
Meridian, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Midwest Behavioral Health
Evansville, Indiana, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Pedia Research, LLC
Newburgh, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Louisiana Research Associates, Inc
New Orleans, Louisiana, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
Psychiatric Care & Research Center
O'Fallon, Missouri, United States
Mid-America Clinical Research, LLC
St Louis, Missouri, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
Insite Clinical Research, LLC
DeSoto, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Thomas Murray DeMoor, MD
San Antonio, Texas, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Zain Research, LLC
Richland, Washington, United States
Dean Foundation for Health Research and Education
Middleton, Wisconsin, United States
Kids Clinic
Ajax, Ontario, Canada
Private Practice of Robert J. Camargo
Newmarket, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
LTD" Rustavi Psychological Health Center"
Rustavi, , Georgia
Leningrad Regional Dispensary of Narcology
Village Novoe Devyatkino, Leningradskaya Oblast', Russia
GBUZ City childrens out-patient clinic # 10 of Moscow
Moscow, , Russia
GOBUZ Murmansk Regional Narcology Dispensary
Murmansk, , Russia
LLC City Neurological Center "Sibneuromed"
Novosibirsk, , Russia
LLC " Alliance Biomedical - Russian Group"
Saint Petersburg, , Russia
LLC Medical Technologies
Saint Petersburg, , Russia
FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
Saint Petersburg, , Russia
LLC Medical Technologies
Saint Petersburg, , Russia
First St. Petersburg State Medical University
Saint Petersburg, , Russia
GBUZ Samara Regional Childrens Health camp Yunost
Samara, , Russia
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CHANTIX
Identifier Type: OTHER
Identifier Source: secondary_id
A3051073
Identifier Type: -
Identifier Source: org_study_id
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