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.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Research Project (R01)
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Human Development Research Subcommittee (NIDA)
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Grossman, Debra
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Stanford University
Internal Medicine/Medicine
Schools of Medicine
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