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Identifying Optimal Smoking Cessation Intervention Components (Cessation) (Cessation)

Primary Purpose

Smoking, Smoking Cessation, Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Counseling before quit attempt
Minimal In-person counseling during quit attempt
Intensive in-person counseling during the quit attempt
Minimal phone counseling during the quit attempt
Intensive phone counseling during the quit attempt
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
Pre-Quit Nicotine Gum
Pre-Quit Nicotine Patch
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
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, Nicotine

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, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk

2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk

3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk

4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk

5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk

6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk

7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk

8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk

11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk

12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk

13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk

14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk

15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk

16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk

17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk

18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk

19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk

20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk

21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk

22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk

23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk

24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk

25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk

26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk

27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk

28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk

29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16

30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W

31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W

32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16

Arm Description

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

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 (16 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 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.

Secondary Outcome Measures

Latency to Relapse
Latency to Relapse during the first 6 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
April 27, 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
NCT01116986
Brief Title
Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Acronym
Cessation
Official Title
Project 2: Identifying Optimal Smoking Cessation Intervention Components
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
The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Arm Title
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Arm Title
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16
Arm Type
Experimental
Arm Description
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Intervention Type
Behavioral
Intervention Name(s)
Counseling before quit attempt
Intervention Description
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intervention Type
Behavioral
Intervention Name(s)
Minimal In-person counseling during quit attempt
Intervention Description
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intervention Type
Behavioral
Intervention Name(s)
Intensive in-person counseling during the quit attempt
Intervention Description
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intervention Type
Behavioral
Intervention Name(s)
Minimal phone counseling during the quit attempt
Intervention Description
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Intervention Type
Behavioral
Intervention Name(s)
Intensive phone counseling during the quit attempt
Intervention Description
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Intervention Type
Drug
Intervention Name(s)
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Intervention Description
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
Intervention Description
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Pre-Quit Nicotine Gum
Intervention Description
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
Intervention Type
Drug
Intervention Name(s)
Pre-Quit Nicotine Patch
Intervention Description
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Intervention Type
Drug
Intervention Name(s)
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
Intervention Description
If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
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 (16 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 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.
Time Frame
16 weeks post-quit
Secondary Outcome Measure Information:
Title
Latency to Relapse
Description
Latency to Relapse during the first 6 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
During the first 6 months post-quit

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
Megan E Piper, PhD
Organizational Affiliation
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timothy B Baker, PhD
Organizational Affiliation
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Official's Role
Principal Investigator
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

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

Identifying Optimal Smoking Cessation Intervention Components (Cessation)

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