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Evaluation of Treatments to Improve Smoking Cessation Medication Adherence (Adherence)

Primary Purpose

Smoking, Smoking Cessation, Adherence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Short Term Combination Nicotine Replacement Therapy (patch + gum)
Long Term Combination Nicotine Replacement Therapy (patch + gum)
Intensive Maintenance Counseling
Cognitive Medication Adherence Counseling (CAM)
Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Automated Adherence Prompting Phone Calls
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Smoking Cessation, Adherence, Nicotine, Motivation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm 30

Arm 31

Arm 32

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1, 26Wks, Counseling, CAM, AutoCalls, Feedback

2, 26Wks, Counseling, CAM, AutoCalls, No Feedback

3, 26Wks, Counseling, CAM, No AutoCalls, Feedback

4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback

5, 26Wks, Counseling, No CAM, AutoCalls, Feedback

6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback

7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback

8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback

9, 26Wks, No Counseling, CAM, AutoCalls, Feedback

10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback

11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback

12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback

13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback

14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback

15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback

16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback

17, 8Wks, Counseling, CAM, AutoCalls, Feedback

18, 8Wks, Counseling, CAM, AutoCalls, No Feedback

19, 8Wks, Counseling, CAM, No AutoCalls, Feedback

20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback

21, 8Wks, Counseling, No CAM, AutoCalls, Feedback

22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback

23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback

24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback

25, 8Wks, No Counseling, CAM, AutoCalls, Feedback

26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback

27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback

28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback

29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback

30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback

31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback

32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback

Arm 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Self-Reported 7-Day Point-Prevalence Abstinence
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

Latency to Relapse
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

Full Information

First Posted
May 3, 2010
Last Updated
November 12, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Dean Health System, Mercy Health System, Aurora Health Care, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01120704
Brief Title
Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Acronym
Adherence
Official Title
Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Dean Health System, Mercy Health System, Aurora Health Care, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation, Adherence, Nicotine Dependence, Motivation
Keywords
Smoking, Smoking Cessation, Adherence, Nicotine, Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1, 26Wks, Counseling, CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
2, 26Wks, Counseling, CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
3, 26Wks, Counseling, CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
5, 26Wks, Counseling, No CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
17, 8Wks, Counseling, CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
18, 8Wks, Counseling, CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
19, 8Wks, Counseling, CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
21, 8Wks, Counseling, No CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
25, 8Wks, No Counseling, CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Arm Title
31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback
Arm Type
Experimental
Arm 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
Arm Title
32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Short Term Combination Nicotine Replacement Therapy (patch + gum)
Intervention Description
IF participant smokes >10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment. IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
Intervention Type
Drug
Intervention Name(s)
Long Term Combination Nicotine Replacement Therapy (patch + gum)
Intervention Description
IF the participant smokes >10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment. IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Maintenance Counseling
Intervention Description
Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 & 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Medication Adherence Counseling (CAM)
Intervention Description
Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Intervention Description
If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).
Intervention Type
Behavioral
Intervention Name(s)
Automated Adherence Prompting Phone Calls
Intervention Description
Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication. Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 & 23.
Primary Outcome Measure Information:
Title
Self-Reported 7-Day Point-Prevalence Abstinence
Description
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.
Time Frame
Assessed at 52 weeks after target quit day
Secondary Outcome Measure Information:
Title
Latency to Relapse
Description
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
Time Frame
Assessed during the first 12 months post-quit after target quit day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Fiore, MD, MPH, MBA
Organizational Affiliation
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanya R Schlam, PhD
Organizational Affiliation
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Official's Role
Study Director
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18783504
Citation
McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Baker TB. Psychological mediators of bupropion sustained-release treatment for smoking cessation. Addiction. 2008 Sep;103(9):1521-33. doi: 10.1111/j.1360-0443.2008.02275.x.
Results Reference
background
PubMed Identifier
32598468
Citation
Schlam TR, Baker TB, Smith SS, Bolt DM, McCarthy DE, Cook JW, Hayes-Birchler T, Fiore MC, Piper ME. Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse. Nicotine Tob Res. 2020 Oct 29;22(11):2051-2058. doi: 10.1093/ntr/ntaa116.
Results Reference
derived
PubMed Identifier
29696311
Citation
Schlam TR, Cook JW, Baker TB, Hayes-Birchler T, Bolt DM, Smith SS, Fiore MC, Piper ME. Can we increase smokers' adherence to nicotine replacement therapy and does this help them quit? Psychopharmacology (Berl). 2018 Jul;235(7):2065-2075. doi: 10.1007/s00213-018-4903-y. Epub 2018 Apr 25.
Results Reference
derived
Links:
URL
http://www.ctri.wisc.edu/
Description
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Learn more about this trial

Evaluation of Treatments to Improve Smoking Cessation Medication Adherence

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