Smoking Cessation Study In Healthy Adolescent Smokers

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Varenicline

Criteria

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.