The primary goal of this proposal is to compare and determine the efficacy and cost effectiveness of three levels of medical/behavioral treatment intensity used in conjunction with the nicotine patch in a diverse population: 1. a minimal control condition consisting of nicotine patch (TNP) detoxification for 8 weeks plus one session consisting of an instructional videotape plus advice and education by a nurse practitioner (n=80); 2. an experimental condition consisting of nicotine detoxification (TNP) plus three additional brief advice and educational (A and E) sessions with a nurse practitioner (A and E; n=80); and 3.) an experimental condition consisting of the foregoing TNP+ A and E treatments combined with 12 weeks of individualized, manually-driven cognitive behavioral therapy (CBT; n=80). Completion of patch treatment and smoking cessation and reduction rates at 9, 26, and 52 weeks post-intake into the study will be the measures of efficacy. Secondary objectives of the research are to examine the moderating effects of a number of variables that may affect response to treatment: 1). determine the extent to which baseline nicotine dependence severity is a negative predictor of treatment response; 2). determine the extent to which low nicotine patch serum cotinine replacement values are a negative predictor of treatment response; 3). compare the treatment response of smokers with and without a history of an Axis I or Axis II psychiatric diagnosis; 4). determine the predictive validity of pretreatment cue reactivity in accounting for outcomes in each treatment condition; 5). determine whether there is a positive relationship between the initial level of motivation to quit smoking and actual smoking cessation; 6). compare the cost effectiveness of the three forms of treatment; and 7). to determine whether any sociodemographic characteristics of the subjects are predictive of treatment response. This proposal requests a fourth year of funding to complete the study as per the requested time period in the original grant application. Progress in the project has been excellent. Subject enrollment has exceeded 9 per month as contrasted with 8 per month originally projected. A paper describing the findings of an earlier pilot study has been published and a paper comparing the concordance between the standard summary method of determining cigarettes smoked and time line followback has been submitted. Three papers are in the late stages of preparation - a paper describing the extent of nicotine patch replacement levels and its relationship to treatment outcome; an examination of patch compliance levels and predictors of patch compliance; and evaluation of the relationship between baseline cue reactivity and treatment response. Findings based on preliminary analysis of the data indicate that subjects with moderate nicotine dependence can effectively be treated with a the low intensity TNP adjunctive treatment, while the high intensity CBT treatment is by far the most effective for those with high nicotine dependence. Further, nearly 100 percent cotinine replacement levels obtained with our 21mg Nicodermal patch raise significant questions about replacement levels achieved by different patch brands. The funding request for year 4 is to complete 70 six or 12 month outcome evaluations and to complete scoring of protocols, data entry, data analysis, and writing reports to describe the study outcomes.
| Gariti, Peter; Alterman, Arthur I; Ehrman, Ronald et al. (2002) Detecting smoking following smoking cessation treatment. Drug Alcohol Depend 65:191-6 |
| Alterman, Arthur I; Gariti, Peter; Niedbala, R Sam (2002) Varying results for immunoassay screening kits for cotinine level. Psychol Addict Behav 16:256-9 |
| Gariti, P; Alterman, A I; Mulvaney, F D et al. (2000) The relationship between psychopathology and smoking cessation treatment response. Drug Alcohol Depend 60:267-73 |
| Gariti, P; Alterman, A I; Barber, W et al. (1999) Cotinine replacement levels for a 21 mg/day transdermal nicotine patch in an outpatient treatment setting. Drug Alcohol Depend 54:111-6 |
| Gariti, P W; Alterman, A I; Ehrman, R N et al. (1998) Reliability and validity of the aggregate method of determining number of cigarettes smoked per day. Am J Addict 7:283-7 |
