The overall goals of this line of research are to develop innovative methods to treat cigarette smokers, and to understand the processes related to smoking and relapse. The proposed research is based upon a chronic disorder model of cigarette smoking that suggests that long-term treatment targeted at relapse precipitants may be useful. Based on this model, we have developed a relapse prevention treatment that uses a cognitive-behavioral framework to intervene on five areas important in relapse prevention, according to the 2000 Practice Guidelines. These areas are fluctuating motivation, depression, withdrawal, weight gain, and social support. [Data] from this line of research and [preliminary data from a] related line of research (Maintaining Abstinence in Chronic Cigarette Smokers, R01 DA015732) suggest that this targeted relapse prevention treatment provided over a one year period can produce CO-verified abstinence rates of [over 50%]. These high rates are maintained at a two year follow-up. It is important to extend these findings from a smoking research clinic to a health care setting, using recruiting procedures, personnel, and patient populations prototypical of health care settings. There is also a need to extend them to smokers with a range of medical and psychiatric disorders. Last, it will be useful to establish the effects of the targeted relapse prevention intervention on abstinence over and above those obtained with extended nonspecific supportive treatment [based on a Health Education model]. Thus, the proposed research will test a series of hypotheses about the efficacy of targeted relapse prevention treatment in relation to extended nonspecific treatment and brief treatment. Participants (N=360) are randomly assigned to one of four experimental conditions. All participants, smokers of e10 cigarettes per day, receive 12 weeks of combined pharmacological treatment (varenicline) and group psychological intervention. During the 40 week extended treatment period, participants will receive either: (1) 40 weeks of varenicline availability + Relapse Prevention Treatment (Relapse Prevention + varenicline);(2) 40 weeks of Relapse Prevention Treatment (Relapse Prevention);(3) 40 weeks of Extended Nonspecific Treatment [based on a Health Education model (Extended Nonspecific) ];and (4) No further treatment (Brief Treatment). Participants will be assessed at baseline on smoking behavior, nicotine dependence, depression diagnosis, alcohol problems, demographics, mood disturbance, treatment support, stress, health status, motivation for change, and licit and illicit drug use. At weeks 12, 24, 52, 64, and 104, participants will be assessed on self-reported smoking verified by carbon monoxide and cotinine assays, as well as on psychometric measures. The primary hypotheses, which posit differences between conditions, will be evaluated by GEE using intent to treat analysis. We will also test a series of secondary hypotheses that evaluate a series of moderating and mediating variables to determine more precisely how treatment is related to abstinence. If this research is successful, it will provide a treatment that produce abstinence rates considerably higher than those obtained from those currently available.

Public Health Relevance

This project evaluates a new treatment for cigarette smokers. In two studies to date, this treatment has produced very high abstinence rates at long-term follow-up. In the current study, we will determine whether it is the content of the treatment, or the increased contact time. We will evaluate the intervention with smokers typical of those seen in a primary care setting. We will also determine whether the abstinence rates obtained in with this treatment are enhanced by adding a new smoking treatment adjunct, varenicline. Cigarette smoking is the number one cause of preventable death in the United States and innovative treatment methods are much needed. The proposed research will contribute to the development of new treatments and their assessment.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA002538-30
Application #
8470595
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Grossman, Debra
Project Start
1980-04-01
Project End
2014-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
30
Fiscal Year
2013
Total Cost
$449,067
Indirect Cost
$87,936
Name
University of California San Francisco
Department
Psychiatry
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Grady, Eric S; Humfleet, Gary L; Delucchi, Kevin L et al. (2014) Smoking cessation outcomes among sexual and gender minority and nonminority smokers in extended smoking treatments. Nicotine Tob Res 16:1207-15
Barnett, Paul G; Wong, Wynnie; Jeffers, Abra et al. (2014) Cost-effectiveness of extended cessation treatment for older smokers. Addiction 109:314-22
Humfleet, Gary L; Hall, Sharon M; Delucchi, Kevin L et al. (2013) A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. Nicotine Tob Res 15:1436-45
Hall, Sharon M; Humfleet, Gary L; Munoz, Ricardo F et al. (2011) Using extended cognitive behavioral treatment and medication to treat dependent smokers. Am J Public Health 101:2349-56
Hendricks, Peter S; Wood, Sabrina B; Baker, Majel R et al. (2011) The Smoking Abstinence Questionnaire: measurement of smokers' abstinence-related expectancies. Addiction 106:716-28
Hendricks, Peter S; Delucchi, Kevin L; Hall, Sharon M (2010) Mechanisms of change in extended cognitive behavioral treatment for tobacco dependence. Drug Alcohol Depend 109:114-9
Hall, Sharon M; Prochaska, Judith J (2009) Treatment of smokers with co-occurring disorders: emphasis on integration in mental health and addiction treatment settings. Annu Rev Clin Psychol 5:409-31
Lawhon, Dawn; Humfleet, Gary L; Hall, Sharon M et al. (2009) Longitudinal analysis of abstinence-specific social support and smoking cessation. Health Psychol 28:465-72
Hall, Sharon M; Humfleet, Gary L; Munoz, Ricardo F et al. (2009) Extended treatment of older cigarette smokers. Addiction 104:1043-52
Hendricks, Peter S; Wood, Sabrina B; Hall, Sharon M (2009) Smokers'expectancies for abstinence: preliminary results from focus groups. Psychol Addict Behav 23:380-5

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