Tailored Nicotine Replacement Therapy for Outpatients

Harvard Pilgrim Health Care, Inc., Boston MA

Investigators

Abstract

DESCRIPTION (Provided by applicant): This project will test the feasibility of a physician and nurse run smoking cessation program that uses transdermal nicotine replacement therapy tailored to match precessation serum cotinine levels. Findings from the proposed pilot study will provide essential information for submission of an RO1 application for a randomized clinical trial. The specific aims of the proposed pilot are to obtain estimates of the: 1) accessibility and availability of subjects in a general internal medicine practice; 2) refusal rates and selection issues; 3) ease of adjusting patch doses based on a protocol; 4) ease of administration of counseling sessions and questionnaires; 5) side effect profile of medications; 6) rates of adherence; 7) relationship between percent nicotine repletion and cessation rates; 8) identify all variables to be included in an application for a randomized controlled trial; 9) develop a database management system. Methodology: 1. Study design a six-month, prospective, double-blinded and randomized pilot study. 2. Subject recruitment--30 adults (15 intervention, 15 usual care), followed by internists at the Cleveland Clinic Foundation, who are currently smoking more than 15 cigarettes per day and have done so over the past six months; after the prospective subjects respond to an advertisement, they will be screened for readiness to change per the transtheoretical model of Prochaska and DiClemente. Patients in the preparation phase will be invited to a screening visit for a physical exam, ECG, and exhaled CO (carbon monoxide) level. 3. Intervention patients in the intervention group will have nicotine patch doses adjusted based on serum cotinine levels, whereas usual care patients will receive patch doses based on a standard protocol, regardless of cotinine levels. All patients will receive person-to-person counseling and telephone support by a nurse. 4. Outcomes measurements: 1) accessibility and availability of subjects in a general internal medicine practice; 2) refusal rates and selection issues; 3) ease of adjusting patch doses based on a protocol; 4) ease of administration of counseling sessions and questionnaires; 5) side effect profile of medications; 6) rates of adherence; 7) relationship between percent nicotine repletion and cessation rates (which will be confirmed by serum cotinine and exhaled CO). In addition, questionnaires will be used to assess quality of life and incidence of depressive symptoms at study?s beginning and end. Significance: Tobacco use has been implicated as the leading avoidable cause of morbidity and mortality in the Unites States. In addition to deleterious effects on the individual?s health, smoking incurs large societal costs as well. This pilot study will provide invaluable information on the feasibility of implementing a physician and nurse run smoking cessation intervention, applicable to general internal medicine practices, tailoring nicotine replacement therapy to varying levels of nicotine dependence.