Smoking Cessation Study In Healthy Adolescent Smokers
- Conditions
- Smoking Cessation
- Interventions
- Registration Number
- NCT01312909
- Lead Sponsor
- Pfizer
- Brief Summary
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 312
- Healthy male and female subjects between the ages of 12 and 19, inclusive.
- 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.
- Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Varenicline 0.5mg BID 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 Placebo Oral placebo for twelve weeks,follow-up through Week 52 Varenicline 1mg BID 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
- Primary Outcome Measures
Name Time Method 4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12 Week 9 through Week 12 The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
- Secondary Outcome Measures
Name Time Method Daily Number of Cigarettes Smoked at Baseline Baseline The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52 Week 9 through Week 24; Week 9 through Week 52 The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52 Weeks 12, 24 and 52 The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52 Baseline, Weeks 12, 24, and 52 The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Trial Locations
- Locations (78)
Private Practice of Robert J. Camargo
🇨🇦Newmarket, Ontario, Canada
Wake Internal Medicine Consultants, Inc
🇺🇸Raleigh, North Carolina, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
GBUZ City childrens out-patient clinic # 10 of Moscow
🇷🇺Moscow, Russian Federation
Pharmax Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
L & L Research Choices
🇺🇸Miami, Florida, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
IICR, Inc. (DBA: International Institute of Clinical Research)
🇺🇸Ozark, Alabama, 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
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
North County Clinical Research
🇺🇸Oceanside, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, 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
Hope Clinical Research
🇺🇸Kissimmee, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Florida Clinical Research Center, LLC
🇺🇸Maitland, 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.
🇺🇸Saint 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
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Louisiana Research Associates, Inc
🇺🇸New Orleans, Louisiana, United States
The Center for Pharmaceutical Research, P.C.
🇺🇸Kansas City, Missouri, United States
Psychiatric Care & Research Center
🇺🇸O'Fallon, Missouri, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, United States
Mid-America Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Kids Clinic
🇨🇦Ajax, Ontario, Canada
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, 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
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Trials of Dallas, L.P.
🇺🇸Dallas, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Insite Clinical Research, LLC
🇺🇸DeSoto, 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
SKDS Research Inc.
🇨🇦New Market, Ontario, Canada
LTD" Rustavi Psychological Health Center"
🇬🇪Rustavi, Georgia
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Leningrad Regional Dispensary of Narcology
🇷🇺Village Novoe Devyatkino, Leningrad Region, Russian Federation
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea St. Vincent Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
GOBUZ Murmansk Regional Narcology Dispensary
🇷🇺Murmansk, Russian Federation
LLC City Neurological Center "Sibneuromed"
🇷🇺Novosibirsk, Russian Federation
LLC " Alliance Biomedical - Russian Group"
🇷🇺Saint-Petersburg, Russian Federation
LLC Medical Technologies
🇷🇺Saint-Petersburg, Russian Federation
FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
🇷🇺Saint-Petersburg, Russian Federation
GBUZ Samara Regional Childrens Health camp Yunost
🇷🇺Samara, Russian Federation
First St. Petersburg State Medical University
🇷🇺Saint-Petersburg, Russian Federation
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
China Medical University Hospital
🇨🇳Taichung city, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States