Youth Smoking Cessation: Therapy +/- "The Patch"
Condition: Smoking
Study type: Interventional

Summary: 
      Reducing tobacco use by adolescents is a national health priority. In recent polls, most
      adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment
      during adolescence has the potential to interrupt the progression to nicotine dependence,
      which is attended by a wide range of negative health consequences. Given the need for
      effective smoking cessation programs aimed at youth, scientifically rigorous research is
      warranted to reduce adolescent smoking. This project will address gaps in the scientific
      treatment literature. The goal of this project is to develop a tailored, practical, and
      efficacious smoking cessation intervention. Combined with other efforts in the field, this
      work can provide an initial guide to an evidence-based treatment for smoking cessation in
      youth.

      In keeping with developments in other fields of medicine, we believe that further advances in
      smoking cessation will move towards a goal of personalized treatment. Such an individualized
      approach for adolescent smoking cessation will be informed by further investigation of the
      relationships between outcomes in this trial. To serve these goals, we propose the following
      program:

      Youths who smoke regularly will receive a 6 week intervention using "cognitive-behavioral
      motivational enhancement" (CBME) supplemented by nicotine replacement therapy (NRT), if youth
      and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day
      in order to qualify for nicotine replacement therapy. This approach is consistent with
      treatment guidelines for smoking cessation (Fiore 2000).

      Compared with participants who fail to achieve smoking cessation, those who successfully
      achieve smoking abstinence during intervention, will have lower baseline rates of comorbid
      ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes
      towards smoking, fewer friends who smoke, and fewer family members who smoke. The
      investigators predict that the intervention will help youth to quit smoking and will examine
      predictions of successful quitting.
    

Detailed description: 
      Tobacco use is the leading preventable cause of death in the United States, and current
      estimates project that 6.4 million of our nation's youth will die prematurely from a
      smoking-related disease (Fellows et al., 2002). Extant data suggest that three of every five
      adolescent smokers are nicotine-dependent, and that some subgroups of adolescents are at
      higher risk for dependence (e.g., daily or heavy smokers, incarcerated youth, youth in
      vocational schools, depressed youth, youth with Attention Deficit Hyperactivity Disorder
      (ADHD)). Adolescent tobacco smoking increases risk for a wide range of negative health
      consequences (Abrantes et al., 2005; Anda et al., 1990; Biederman et al., 2006; Escobedo et
      al., 1998; Kandel et al., 1986; Kollins et al., 2005; Wilens & Dodson 2004). For example,
      smoking-related cancer risk is increased with early age of initiating smoking and longer time
      of smoking, underscoring the importance of addressing this health risk behavior in youth
      (Centers for Disease Control and Prevention, 1994).

      Reducing tobacco use by adolescents is a national health priority (see Healthy People 2010,
      Objective, 27.2 (Office of Disease Prevention and Health Promotion 2000)). Approximately 4%
      of 8th graders, 7.5% of 10th graders, and 13.6% of 12th graders smoke daily and almost half
      of these youths smoke ≥ half a pack per day (Johnston & O'Coner 2005). In recent polls, most
      adolescent smokers reported having tried unsuccessfully to quit (Grimshaw et al., 2003;
      Hollis et al., 2003). Smoking cessation treatment during adolescence has the potential to
      interrupt the progression to nicotine dependence, which is attended by a wide range of
      negative health consequences (Anda et al., 1990; Escobedo et al., 1998; Kandel & Davies
      1986). Given the need for effective smoking cessation programs aimed at youth, scientifically
      rigorous research is warranted to reduce adolescent smoking (Backinger et al., 2003). This
      project will address gaps in the scientific treatment literature.

      In keeping with developments in other fields of medicine, we believe that further advances in
      smoking cessation will move towards a goal of personalized treatment. In order to optimize
      the aim for personalized treatment we will include genetic testing. For some smoking
      cessation treatments, evidence has begun to accumulate that the inter-individual variability
      in response to treatment benefits and side effects may be influenced by inheritance. In the
      smoking cessation treatment literature, some observations have already been made suggesting
      that common gene variants may be associated with different treatment outcomes. The
      association between depression and smoking has led to interest in whether the short allele of
      the serotonin transporter gene may be associated with increased vulnerability to smoking and
      nicotine dependence, although to our knowledge this has yet to be demonstrated (Brody, et al.
      2005). Such findings suggest that individual vulnerability to the reinforcing effects of
      smoking, and most important to this study differences in quitting success, could be partially
      predicted by individual genotype. Additionally, motivational and psychosocial factors have
      also been identified as likely predictors of treatment response. We are seeking predictors
      that would allow us to reach the ultimate objective: to contribute to an algorithm to better
      match youth and effective smoking cessation treatment.

      Specific Aims of the study are as follows:

        1. To evaluate an intervention for adolescent smoking cessation.

        2. To examine moderators and mediators of successful smoking cessation.
    

Intervention name(s): CBME; Optional NRT
Intervention type(s): Behavioral; Drug
Intervention description(s): 6 weeks of once a week one-on-one CBME; NicoDerm CQ nicotine transdermal patch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Youth; Smoking; Tobacco; Adolescent; Dependence; Teen smoking; Smoking and youth; Youth and tobacco