Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | May 2014 |
Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Many smokers fail to take their smoking cessation medication as recommended. This research
is designed to identify treatments that improve the use of cessation medications and to
determine whether an increase in medication use results in increased cessation success. This
research will also identify treatments that help people stay quit after a quit attempt and
will pioneer more efficient research methods.
is designed to identify treatments that improve the use of cessation medications and to
determine whether an increase in medication use results in increased cessation success. This
research will also identify treatments that help people stay quit after a quit attempt and
will pioneer more efficient research methods.
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.
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.
We found this trial at
1
site
Madison, Wisconsin 53711
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