Research indicates that drug addictions are chronic, relapsing disorders requiring extended therapy and follow-up. However, only a few smoking cessation trials have examined the utility of extended therapy models. We propose to examine the efficacy of a multi-component extended cigarette smoking cessation treatment in promoting longer-term smoking abstinence. Adult smokers and adolescent smokers (18 - 21) years of age will serve as the target population for this study. A total of 400 smokers will be randomized. Treatment will include both open label and extended treatment phases. Open Label Treatment. All 400 smokers will receive nicotine patch (21mg), bupropion (300mg) and individualized cognitive and behavioral skills training (ST). Nicotine patches and bupropion will be provided for 10 weeks and cognitive behavior therapy (CBT) will be provided for 26 weeks. Those who fail to respond to bupropion and nicotine patch will be switched to varenicline through week 26. Those who relapse beyond week 10 will re-start bupropion and nicotine patch through week 26. Extended Treatment. Following open label treatment, half (n=200) will receive CBT from week 26 - week 52. CBT will include both therapist-directed and self-directed relapse prevention skills training. In addition, telephone counseling will be provided in conjunction with voicemail, computer and cell phone technology enabling monitoring of treatment plan implementation and early detection of smoking """"""""slips"""""""" and rapid response by treatment staff. Control. Remaining participants (n=200) will receive monthly telephone support calls from week 26 - week 52. The proposed study will address several important gaps in our knowledge of effective smoking cessation treatment. First, this will be one of only a handful of studies to investigate the effects of extended therapy for smoking cessation. Second, this will be among the first controlled studies to examine the effects of a multi-component treatment employing pharmacotherapy, intensive behavioral skills training, self-help skills training and rapid slip detection and response via voicemail, cell phone and telephone counseling.

Public Health Relevance

Cigarette smoking is a major public health problem. This study is designed to study the efficacy of an extended smoking cessation treatment.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA017441-07
Application #
8091208
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Grossman, Debra
Project Start
2003-09-15
Project End
2014-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
7
Fiscal Year
2011
Total Cost
$585,473
Indirect Cost
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
David, Sean P; Naudet, Florian; Laude, Jennifer et al. (2018) Potential Reporting Bias in Neuroimaging Studies of Sex Differences. Sci Rep 8:6082
Laude, Jennifer R; Bailey, Steffani R; Crew, Erin et al. (2017) Extended treatment for cigarette smoking cessation: a randomized control trial. Addiction 112:1451-1459
Leyro, Teresa M; Crew, Erin E; Bryson, Susan W et al. (2016) Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence. BMJ Open 6:e010960
David, Sean P; Wang, Ange; Kapphahn, Kristopher et al. (2016) Gene by Environment Investigation of Incident Lung Cancer Risk in African-Americans. EBioMedicine 4:153-61
Strong, David R; Hartman, Sheri J; Nodora, Jesse et al. (2015) Predictive Validity of the Expanded Susceptibility to Smoke Index. Nicotine Tob Res 17:862-9
Sarginson, Jane E; Killen, Joel D; Lazzeroni, Laura C et al. (2015) Response to Transdermal Selegiline Smoking Cessation Therapy and Markers in the 15q24 Chromosomal Region. Nicotine Tob Res 17:1126-33
Strong, David R; David, Sean P; Johnstone, Elaine C et al. (2015) Differential Efficacy of Nicotine Replacement Among Overweight and Obese Women Smokers. Nicotine Tob Res 17:855-61
Ioannidis, John P A; Munafò, Marcus R; Fusar-Poli, Paolo et al. (2014) Publication and other reporting biases in cognitive sciences: detection, prevalence, and prevention. Trends Cogn Sci 18:235-41
David, Sean P; Chu, Isabella M; Lancaster, Tim et al. (2014) Systematic review and meta-analysis of opioid antagonists for smoking cessation. BMJ Open 4:e004393
Xu, Xiaomeng; Clark, Uraina S; David, Sean P et al. (2014) Effects of nicotine deprivation and replacement on BOLD-fMRI response to smoking cues as a function of DRD4 VNTR genotype. Nicotine Tob Res 16:939-47

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