Smoking Cessation Study In Healthy Adolescent Smokers

Phase 4

Completed

Interventions: Drug: Varenicline 0.5mg BID
Drug: Placebo
Drug: Varenicline 1mg BID

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

Recruitment & Eligibility

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.

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.

Locations (78): 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
Scroll for more (68 remaining)
IICR, Inc. (DBA: International Institute of Clinical Research)
🇺🇸Ozark, Alabama, United States