The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
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
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
Oral placebo for twelve weeks,follow-up through Week 52
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From 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).
Time frame: Week 9 through Week 12
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at 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.
Time frame: Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Time frame: Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at 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.
Time frame: Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and 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.
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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
...and 70 more locations
Time frame: Week 9 through Week 24; Week 9 through Week 52