|Grant Number:||5R01CA080268-04 Interpret this number|
|Primary Investigator:||Killen, Joel|
|Project Title:||Nrt & Zyban for Smoking Cessation Among High-Risk Teens|
Research indicates that nicotine dependence assumes a prominent role alongside psychosocial factors in maintaining smoking among adolescents and that nicotine dependence must be addressed directly in smoking cessation efforts targeting adolescents. However, no controlled trials of pharmacotherapy for adolescent smoking cessation have appeared in the literature. Therefore, the primary aim of this study is to examine the efficacy of a treatment approach in combining buproprion, NRT and group-based skills training (GST) in promoting smoking cessation and preventing relapse among adolescent smokers. The primary hypothesis is that adolescent smokers randomized to receive buproprion + NRT + GST will have a higher abstinence rate at 6 month follow-up than those who receive placebo + NRT + GST. Abstinence will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking (not even a puff) for seven consecutive days prior to contact plus a saliva cotinine level below 20 ng/ml. Adolescent smokers (N=300) found eligible will receive nicotine patch couples with GST for smoking cessation. In addition, they will be randomized to receive either buproprion (150 mg) or placebo. Therefore, the study will be comprised of the following two groups: (1) buproprion +NRT +GST (n=150); (2) placebo + NRT + GST (n=150). The proposed research study will address several important gaps in our knowledge of effective smoking cessation treatments for adolescents. First, it will be one of the first controlled studies in adults or adolescents to examine the efficacy of a smoking cessation treatment combining NRT with antidepressant medication. Second, it will be perhaps the first controlled study with adolescent smokers to examine the effects of antidepressant medication on depression symptomatology which often emerges during the course of treatment. The study will provide important practical information to the medical and health communities concerning the utility of antidepressant medication for smoking cessation in adolescent populations and will advance our knowledge of the underlying relationship of nicotine addiction and depression.