Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
This trial is active, not recruiting.
|Conditions||smoking, smoking cessation, adherence, nicotine, motivation|
|Treatments||short term combination nicotine replacement therapy (patch + gum), long term combination nicotine replacement therapy (patch + gum), intensive maintenance counseling, cognitive medication adherence counseling (cam), electronic medication monitoring device (the helping hand) + feedback, automated adherence prompting phone calls|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||Dean Health System|
|Start date||June 2010|
|End date||May 2014|
|Trial size||544 participants|
|Trial identifier||NCT01120704, 9P50CA143188, H-2010-0049|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||single blind (outcomes assessor)|
Latency to Relapse
time frame: Assessed during the first 12 months post-quit after target quit day
7-day point prevalence abstinence
time frame: Assessed at weeks 8, 16, 26, 39, and 52 after the target quit day.
Nicotine Gum Adherence
time frame: Assessed for 8 or16 weeks after the target quit day. (See description below.)
Male or female participants at least 18 years old.
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.
|Official title||Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications|
|Principal investigator||Michael C Fiore, MD, MPH, MBA|
|Description||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.|
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