Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Nonadherent use of smoking cessation medications is very common and highly associated with
cessation failure. However, little is presently known about how to improve adherence and
whether improved adherence will actually boost cessation success (i.e., its causal role is
unknown). This research represents groundbreaking integration of 1) basic theory and data
on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art
Intervention Optimization Cycle methodology. This methodology uses factorial designs to
efficiently engineer and evaluate intervention components, and to develop an optimal
comprehensive treatment package. Participants in Project 3 will be smokers (N = 544)
visiting primary care clinics for a regular outpatient visit who, when asked, express an
interest in quitting and agree to participate in a smoking cessation research study. The
experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a
50% chance of being assigned one of the levels of each factor. The five factors include one
medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance
counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive
Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication
monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone;
and 3) automated adherence prompting phone calls vs. no prompting.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Medication Adherence
We will integrate multiple adherence measures: electronic medication monitoring device (Helping Hand) data, used nicotine patch sleeves, automated phone call and questionnaire data to assess medication adherence. In Visits 2-5 we will: 1) download Helping Hand data to assess removing the blister pack of gum from the medication monitor; 2) count used patch sleeves, and 3) collect self-report data to assess gum adherence over the past 7 days and patch adherence using time-line follow-back since prior contact.
Assessed for 26 weeks (depending on the condition) after the target quit day.
No
Michael C Fiore, MD, MPH, MBA
Principal Investigator
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
United States: Institutional Review Board
H-2010-0049
NCT01120704
June 2010
March 2014
Name | Location |
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison, Wisconsin 53711 |