In Phase 1, the investigators will revise the distress tolerance (DT) protocol the investigators developed in a previous study. Currently, the DT protocol is comprised of 6 two-hour weekly group sessions. However, based on the data the investigators collected in the previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT protocol. All subjects in the pilot will receive the transdermal nicotine patch (TNP). Prior to initiating use of the TNP on quit day, all subjects will be educated about its use and instructed to comply with all the recommended guidelines for usage as outlined in the directions. Smokers who lapse during treatment will be encouraged to set a new quit date and continue to attempt to quit. Subjects who continue to smoke or lapse after quit day will not be instructed to discontinue the patch unless their smoking level reaches 4 cigarettes/day for 4 days. This recommendation is consistent with safe TNP use. Smoking cessation will be objectively verified by expired carbon monoxide levels and saliva cotinine assays. Specifically, subjects who self-report nicotine abstinence will provide an exhaled breath into a Bedfont Micro Smokerlyzer to measure carbon monoxide levels and provide an adequate amount of saliva for cotinine analyses. RAs will wear non-latex gloves and follow all safety protocols for data collection and storage for biochemical materials. the investigators will use an 8ppm cutoff for expired carbon monoxide levels for stated abstinence of 24 hours for 2 weeks and use a cutoff of 10ng/ml for saliva cotinine assays for stated abstinence of 2 weeks or more as cotinine may be incompletely metabolized before this time. Expired carbon monoxide results will be immediately available. Saliva samples will be frozen for shipment to the American Health Foundation (Valhalla, NY) for cotinine level determination by radioimmune assay. Detected values above the stated cutoffs will be considered indicative of smoking. Therefore, smoking cessation and weight loss will be assessed using expired carbon monoxide and weigh-ins during the intervention and saliva cotinine assays and weigh-ins at follow-ups. During Phase 1 post-intervention follow-up, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to make sure it equates for intervention contact time.
In Phase 2, 48 subjects (8 groups of 6) will be recruited. Both conditions will receive the TNP and follow the protocol previously outlined in Phase 1. Once 6 eligible subjects are recruited, random assignment will be used to determine which of the two treatment conditions the group will receive. We expect to recruit 6 subjects within two weeks, reducing the lag time between a subject's eligibility and starting the intervention. Compensation for subjects' time will also support timely recruitment. To ensure an equal number of groups are assigned to each of the two conditions, assignment will be completed by choosing from among a fixed pool of 8 entries (4 from each condition). Smoking cessation and weight loss outcomes will be assessed using biochemical measures and weigh-ins during the intervention and at follow-up.
