The primary goal of this proposal is to compare and determine the effectiveness of three levels of medical/behavioral treatment intensity used in conjunction with the nicotine patch in a diverse population. The major specific objective is to compare the short and long term efficacy, as well as the cost-effectiveness, of three levels of treatment: 1. - a minimal control condition consisting of nicotine patch detoxification for 8 weeks plus one session consisting of an instructional videotape + advice and education by a nurse practitioner (NP; n=80); 2. an experimental condition consisting of nicotine detoxification plus three additional brief advice and educational (A&E) sessions with a nurse practitioner (A&E; n=80) and 3.) an experimental condition consisting of the foregoing A&E treatment combined with 12 weeks of individualized, manually-driven cognitive behavioral therapy (CB; 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: l). to determine the extent to which baseline nicotine dependence severity is a negative predictor of treatment response, reflected in treatment completion and in smoking cessation and reduction rates; 2). to determine the extent to which low nicotine patch serum cotinine replacement values are a negative predictor of treatment response; 3). to compare treatment completion rates and smoking cessation/reduction rates in smokers with versus without a history of an Axis I/II disorder; 4). to determine the predictive validity of pre- and treatment cue reactivity in accounting for outcomes in each treatment condition; 5). to 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 subject are predictive of treatment response. This is an outpatient, prospective, matched, random assignment, experimental study which will take place over a five year period. Two hundred forty (n=240) nicotine dependent cigarette smokers will be randomized over a three year period. All groups must complete patch treatment in eight weeks from the start of patch treatment. Abstinence at the 9, 26, and 52 week post-intake followup evaluations will be based on a combination of self report, CO readings, and urine cotinine data. Other measures will include the Fagerstrom Nicotine Addiction questionnaire, the Shiffman-Jarvik Smoking Withdrawal questionnaire, time line followback for weekly cigarette use for six months prior t treatment and for the 52 weeks following entry into the study, Axis I and Axis II semi-structured interviews, serum cotinine levels prior to and following use of the patch, cue reactivity data, the URICA measure of motivation, cost and cost effectiveness data, the SCL-90, and urine drug screens and blood alcohol concentrations. Assessments will be done at 0, 3, 6, 9, 26, and 52 weeks. The study findings will inform the treatment community about the most effective and cost effective patch treatments; the association between a number of significant subject variables and treatment response, and the most effective combination of patch treatment for indivIduals with different kinds of presenting problems.
| 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 |
