Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Phase 4
Completed
- Conditions
- Nicotine DependenceSmokingSmoking CessationAdherenceMotivation
- Interventions
- Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)Behavioral: Intensive Maintenance CounselingBehavioral: Cognitive Medication Adherence Counseling (CAM)Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + FeedbackBehavioral: Automated Adherence Prompting Phone Calls
- Registration Number
- NCT01120704
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 544
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 1, 26Wks, Counseling, CAM, AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 1, 26Wks, Counseling, CAM, AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 1, 26Wks, Counseling, CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 1, 26Wks, Counseling, CAM, AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 1, 26Wks, Counseling, CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 17, 8Wks, Counseling, CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 17, 8Wks, Counseling, CAM, AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 17, 8Wks, Counseling, CAM, AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback Long Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 17, 8Wks, Counseling, CAM, AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 17, 8Wks, Counseling, CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback Intensive Maintenance Counseling This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback Cognitive Medication Adherence Counseling (CAM) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback Electronic Medication Monitoring Device (the Helping Hand) + Feedback This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback Automated Adherence Prompting Phone Calls This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback Short Term Combination Nicotine Replacement Therapy (patch + gum) This arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
- Primary Outcome Measures
Name Time Method Self-Reported 7-Day Point-Prevalence Abstinence Assessed at 52 weeks after target quit day Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.
Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence.
- Secondary Outcome Measures
Name Time Method Latency to Relapse Assessed during the first 12 months post-quit after target quit day Latency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie nicotine dependence and how do NRT formulations address these pathways?
How does cognitive medication adherence counseling compare to standard behavioral interventions in smoking cessation outcomes?
What biomarkers are associated with successful long-term adherence to combination nicotine replacement therapy?
What adverse events are commonly reported with extended duration NRT and how are they managed in clinical practice?
How do electronic medication monitoring devices like the Helping Hand impact adherence rates compared to traditional methods in nicotine dependence treatment?
Trial Locations
- Locations (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health🇺🇸Madison, Wisconsin, United States