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Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications

Phase 4
18 Years
Open (Enrolling)
Smoking, Smoking Cessation, Adherence, Nicotine, Motivation

Thank you

Trial Information

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.

Inclusion Criteria:

- 18 years of age or older;

- Report smoking at least 5 cigarettes per day for the previous 6 months;

- Able to read and write English;

- Agree to attend visits, to respond to coaching calls, and to respond to Interactive
Voice Response (IVR) phone prompts;

- Plans to remain in the intervention catchment area for at least 12 months;

- Currently interested in quitting smoking (defined as would like to try to quit in the
next 30 days).

- All women of childbearing potential will be required to agree to use an acceptable
method of birth control to prevent pregnancy during the study.

Exclusion Criteria:

- Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is
not exclusionary if the participant agrees to use only study medication for the
duration of the study);

- Study candidate is pregnant, trying to get pregnant, or nursing.

- A history of psychosis or bipolar disorder

- A history of skin or allergic reactions while using a nicotine patch.

- Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Medication Adherence

Outcome Description:

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.

Outcome Time Frame:

Assessed for 26 weeks (depending on the condition) after the target quit day.

Safety Issue:


Principal Investigator

Michael C Fiore, MD, MPH, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

March 2014

Related Keywords:

  • Smoking
  • Smoking Cessation
  • Adherence
  • Nicotine
  • Motivation
  • Smoking
  • Smoking Cessation
  • Adherence
  • Nicotine
  • Motivation
  • Smoking



University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health Madison, Wisconsin  53711