Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Status and phase
Completed
Phase 4
Conditions
Motivation
Nicotine Dependence
Adherence
Smoking
Smoking Cessation
Treatments
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Behavioral: Automated Adherence Prompting Phone Calls
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Intensive Maintenance Counseling
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
Study type
Interventional
Funder types
Other
NETWORK
NIH
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
544 patients
Sex
All
Ages
18 to 99 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Single Blind
544 participants in 32 patient groups
1, 26Wks, Counseling, CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
2, 26Wks, Counseling, CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
3, 26Wks, Counseling, CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
5, 26Wks, Counseling, No CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Automated Adherence Prompting Phone Calls
15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
17, 8Wks, Counseling, CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
18, 8Wks, Counseling, CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Behavioral: Automated Adherence Prompting Phone Calls
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
19, 8Wks, Counseling, CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Intensive Maintenance Counseling
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
21, 8Wks, Counseling, No CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Behavioral: Automated Adherence Prompting Phone Calls
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Intensive Maintenance Counseling
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
25, 8Wks, No Counseling, CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Automated Adherence Prompting Phone Calls
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Cognitive Medication Adherence Counseling (CAM)
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Automated Adherence Prompting Phone Calls
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Automated Adherence Prompting Phone Calls
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback
Experimental group
Description:
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
Treatment:
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback
Experimental group
Description:
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
Treatment:
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
Trial contacts and locations
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