Smoking Cessation Study In Healthy Adolescent Smokers



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 19
Updated:8/11/2018
Start Date:April 2011
End Date:January 2018

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A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

The study is designed to see if varenicline combined with age appropriate (adolescent)
smoking cessation counseling will help teens quit smoking.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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1000 Regency Court
Toledo, Ohio 43623
419-841-7369
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Ajax, Ontario
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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13001 E 17th Pl
Aurora, Colorado 80045
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University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Bardstown, Kentucky 40004
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Colorado Springs, Colorado 80910
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New Haven, Connecticut 6520
(203) 432-4771
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Raleigh, North Carolina 27612
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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