Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 544
- 试验地点
- 1
- 主要终点
- Self-Reported 7-Day Point-Prevalence Abstinence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1, 26Wks, Counseling, CAM, AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
1, 26Wks, Counseling, CAM, AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
1, 26Wks, Counseling, CAM, AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
1, 26Wks, Counseling, CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
1, 26Wks, Counseling, CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
2, 26Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
2, 26Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
2, 26Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
2, 26Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
3, 26Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
3, 26Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
3, 26Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
3, 26Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
4, 26Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
4, 26Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
4, 26Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
5, 26Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
5, 26Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
5, 26Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
5, 26Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
6, 26Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
6, 26Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
6, 26Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
7, 26Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
7, 26Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
7, 26Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
8, 26Wks, Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
8, 26Wks, Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
9, 26Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
9, 26Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
9, 26Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
9, 26Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
10, 26Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
10, 26Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
10, 26Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
11, 26Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
11, 26Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
11, 26Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
12, 26Wks, No Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
12, 26Wks, No Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
13, 26Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
13, 26Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
13, 26Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
14, 26Wks, No Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
14, 26Wks, No Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
15, 26Wks, No Counseling, No CAM, No AutoCalls, 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
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
15, 26Wks, No Counseling, No CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
16, 26Wks, No Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
17, 8Wks, Counseling, CAM, AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
17, 8Wks, Counseling, CAM, AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
17, 8Wks, Counseling, CAM, AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
17, 8Wks, Counseling, CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
17, 8Wks, Counseling, CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
18, 8Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
18, 8Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
18, 8Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
18, 8Wks, Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
19, 8Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
19, 8Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
19, 8Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
19, 8Wks, Counseling, CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
20, 8Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
20, 8Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
20, 8Wks, Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
22, 8Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
21, 8Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
21, 8Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
21, 8Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
21, 8Wks, Counseling, No CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
22, 8Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
22, 8Wks, Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
23, 8Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
23, 8Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Intensive Maintenance Counseling (Behavioral)
23, 8Wks, Counseling, No CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
24, 8Wks, Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
24, 8Wks, Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Intensive Maintenance Counseling (Behavioral)
25, 8Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
25, 8Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
25, 8Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
25, 8Wks, No Counseling, CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
26, 8Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
26, 8Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
26, 8Wks, No Counseling, CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
27, 8Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
27, 8Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
27, 8Wks, No Counseling, CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
28, 8Wks, No Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
28, 8Wks, No Counseling, CAM, No AutoCalls, No 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 but No Feedback
干预措施: Cognitive Medication Adherence Counseling (CAM) (Behavioral)
29, 8Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
29, 8Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
29, 8Wks, No Counseling, No CAM, AutoCalls, 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
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
30, 8Wks, No Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
30, 8Wks, No Counseling, No CAM, AutoCalls, No 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 but No Feedback
干预措施: Automated Adherence Prompting Phone Calls (Behavioral)
31, 8Wks, No Counseling, No CAM, No AutoCalls, 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
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
31, 8Wks, No Counseling, No CAM, No AutoCalls, 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
干预措施: Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral)
32, 8Wks, No Counseling, No CAM, No AutoCalls, No 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 but No Feedback
干预措施: Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug)
结局指标
主要结局
Self-Reported 7-Day Point-Prevalence Abstinence
时间窗: 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.
次要结局
- Latency to Relapse(Assessed during the first 12 months post-quit after target quit day)