Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00631020
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2008-02-27
Brief Title:
Youth Smoking Cessation Therapy - The Patch
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Determining the Efficacy of Cognitive-behavioral Motivational Enhancement - Nicotine Replacement Therapy for Adolescents
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 64 million of our nations 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 eg 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 272 Office of Disease Prevention and Health Promotion 2000 Approximately 4 of 8th graders 75 of 10th graders and 136 of 12th graders smoke daily and almost half of these youths smoke half a pack per day Johnston OConer 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
Reducing tobacco use by adolescents is a national health priority see Healthy People 2010 Objective 272 Office of Disease Prevention and Health Promotion 2000 Approximately 4 of 8th graders 75 of 10th graders and 136 of 12th graders smoke daily and almost half of these youths smoke half a pack per day Johnston OConer 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None