Youth Smoking Cessation: Therapy +/- The Patch

Study Overview
=================
Brief 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: To evaluate an intervention for adolescent smoking cessation. To examine moderators and mediators of successful smoking cessation.

Official Title
-----------------
Determining the Efficacy of Cognitive-behavioral Motivational Enhancement +/- Nicotine Replacement Therapy for Adolescents

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: CBME
* Drug: Optional NRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must meet all of the following inclusion criteria: age of 14-21 years, inclusive regular cigarette smoking at least five times a day in the month before entry into the study and initiation of smoking at least 6 months before entry A score of 35 or greater on the Cigarette Dependence Scale-12 youth provide informed assent (for youth <18 yr) or consent (for youth ≥18 yr) and parents provide informed consent to participate in the project documented approval to participate from the participant's treating physician for participants currently receiving treatment for a serious medical or psychiatric condition current contact information (address, telephone number), which is needed for follow-up able to complete study assessments and participate in the intervention (e.g., lives < 1 hr. away from the site, has family to participate in the intervention, does not have mental retardation) youth or primary caregivers speak English or Spanish Exclusion Criteria: Participants must meet none of the following exclusion criteria in order to be eligible to receive optional nicotine replacement: smoke less than 5 cigarettes per day have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch have a known allergy to nicotine or any component of the nicotine patches be receiving treatment with adenosine or bupropion due to potential drug-drug interactions be pregnant or sexually active and not using reliable birth control methods consistently (for females)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBME +/- NRT<br>6 weeks CBME with optional 4 weeks NRT | Behavioral: CBME<br>* 6 weeks of once a week one-on-one CBME<br>Drug: Optional NRT<br>* NicoDerm CQ nicotine transdermal patch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of Nicotine Replacement Therapy | Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured. | week 2 | 
| Retention in Trial | Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no) | week 6 | 
| 7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24) | The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm. | week 6, 12, 16 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Tobacco Withdrawal Symptoms Compared to Baseline | Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined. | Weeks 6, 12, 16 and 24 | 
| Change in Tobacco Dependence Compared to Baseline | Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured. | Weeks 6, 12, 16 and 24 | 
| Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline | Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point. | Weeks 6, 12, 16 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Youth, Smoking, Tobacco, Adolescent, Dependence, Teen smoking, Smoking and youth, Youth and tobacco