Methods: Smokers willing to quit were recruited from 11 primary care clinics in Wisconsin and were randomly assigned to one of two MOST cessation trials. Study 1 (N=637) used a fractional factorial design to assess 6 interventions that focused on the Preparation and Cessation Phases: 1) Pre-quit Nicotine Patch vs. No Nicotine Patch, 2) Pre-quit Nicotine Gum vs. No Nicotine Gum, 3) Pre-quit Counseling vs. None, 4) 16 vs. 8 Weeks of Nicotine Patch + Nicotine Gum, 5) Intensive In-person Counseling vs. Minimal, and 6) Intensive Phone Counseling vs. Minimal. Study 2 (N=545) used a full factorial design to assess 5 intervention components that focused on the Maintenance Phase and medication adherence: 1) 26 vs. 8 Weeks of Nicotine Patch + Nicotine Gum, 2) Maintenance Phone Counseling vs. None, 3) Cognitive Medication Adherence Counseling (C-MAC) vs. None, 4) Electronic Medication Monitoring Device + Adherence Feedback vs. Medication Monitoring Device Only, and 5) Automated Adherence Prompting Calls vs. None.
Results: Across these two studies we identified intervention components with significant effects on phase-specific outcomes. For instance, Intensive In-person Counseling produced significantly higher initial cessation rates (p<.05) and reduced post-quit cravings (p < .05) relative to Minimal In-person Counseling; 26 weeks of combination nicotine replacement therapy (NRT) significantly increased 26-week abstinence rates relative to 8 weeks of combination NRT (p<.05). With respect to adherence interventions, we found that Maintenance Counseling interacted with C-MAC to produce the highest nicotine patch and nicotine gum adherence rates from Weeks 3-6 (p<.05).
Conclusions: The results from these two studies are being used to develop an optimized smoking cessation treatment package that includes only effective intervention components that work well together in real-world healthcare settings. These optimized treatments will then be compared with Usual Care treatment to demonstrate real-world optimization of smoking treatment.