Identifying Treatments to Motivate Smokers to Quit

Phase 4

Completed

Conditions: Smoking
Smoking Cessation
Motivation
Nicotine Dependence

Interventions: Behavioral: Motivational Interviewing
Drug: Nicotine Patch
Other: No Intervention
Drug: Nicotine Gum
Behavioral: Smoking Reduction
Drug: Nicotine Patch + Nicotine Gum

Registration Number: NCT01122238

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: At any given point in time, most smokers are not interested in making a serious quit attempt. Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date, 30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While \~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term success. This means that of the more than 60 million Americans who smoke, only 1 million are able to quit each year. If we could double the number of quit attempts and maintain comparable success rates, we could double the number of individuals who will benefit from living smoke free lives. These observations underscore the need to develop interventions that increase smokers' motivation or willingness to make quit attempts, and that also increase the rate of success among those who attempt to quit. The overall goal of this proposed experiment is to identify effective interventions aimed at increasing motivation for smoking cessation, increasing quit attempts, and increasing rates of cessation success. Interventions that will be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing, and smoking reduction counseling. At minimum, all participants will complete surveys about their smoking behavior that might increase their motivation to eventually quitting smoking.

Detailed Description: This study used efficient research methods to screen four intervention components (Nicotine Patch, Nicotine Gum, Motivational Interviewing, Behavioral Reduction Counseling) that were designed to reduce smoking heaviness, enhance quitting success, and be easily translated into healthcare settings. These components were evaluated amongst smokers recruited in primary care who were unwilling to make a quit attempt, but who were willing to reduce their smoking. The main objective was to identify promising Motivation phase components for inclusion in a comprehensive chronic care smoking treatment.

Recruitment and Enrollment:

Participants were recruited from 11 primary care clinics in southern Wisconsin using existing rooming staff (i.e., medical assistants) who were prompted by electronic health record technology. During clinic visits, identified smokers were invited to participate in a research program to help them reduce their smoking. Interested patients were electronically referred to the research office. Research staff contacted interested patients and assessed eligibility. Eligible patients were invited to return to their primary care clinic to learn about the study, provide written informed consent, be randomized, and complete initial assessments. A database created a schedule of intervention and assessment contacts, which guided treatment delivery by case managers. The case managers in this study were bachelor's level research staff.

There was an initial 6-week Motivation phase treatment period, and participants could choose to extend the treatment for another 6 weeks (so Motivation phase treatment lasted either 6 or 12 weeks). Participants who chose to extend the treatment continued to receive the same components to which they were originally, randomly assigned. In addition, participants could elect to receive Cessation phase treatment at any point throughout the 6-month study period. Cessation phase treatment was identical for all participants and consisted of 8 weeks of nicotine patch + nicotine gum, and two brief phone counseling sessions.

Study Design:

This 2x2x2x2 factorial experiment had four factors each comprising an active (ON) condition and control (OFF) condition: 1) Nicotine Patch; 2) Nicotine Gum; 3) Motivational Interviewing; and 4) Behavioral Reduction Counseling, yielding 16 unique combinations of experimental conditions. Subjects were randomly assigned to one of the 16 experimental conditions, stratifying by gender. All treatment components were designed to be compatible with one another, and to be delivered with fidelity across all treatment combinations.

Experimental Factors:

Nicotine Patch vs. No Patch. Participants in the ON (active) condition were instructed to use 14-mg patches daily for the 6-week intervention period.

Nicotine Gum vs. No Gum. Participants in the ON condition were instructed to use 2-mg nicotine gum for the 6-week intervention period (≥9/day, 1 piece/1-2 hours) in place of smoking.

Motivational Interviewing (MI) vs. No MI. Participants in the ON condition received an initial 20-minute in-person counseling session followed by three 20-minute counseling calls over the 6-week intervention period. As per Miller and Rollnick (50, 51), the counseling sessions included motivation-building exercises to reinforce intrinsic motivation and to help participants overcome ambivalence about quitting.

Behavioral Reduction (BR) vs. No BR. Participants in the ON condition received an initial 20-minute in-person counseling session followed by 6 weekly 20-minute counseling calls. During these sessions, participants set smoking reduction goals and developed reduction strategies (e.g., delaying smoking, eliminating smoking in specific situations). Participants were also instructed to record daily smoking, which case managers used to identify successes and challenges.

Assessments:

Participants completed baseline assessments of vital signs, demographics, and smoking history and dependence (e.g., the Fagerström Test for Nicotine Dependence). During study visits, adverse events, medication adherence, and smoking in the past week were assessed. The last was used to determine the primary outcome of cigarettes smoked per day (CPD) at 12 and 26 weeks, as well as 7-day point-prevalence abstinence (no smoking for the past 7 days) at 26 weeks post study entry. Smoking heaviness reflects both smoking reduction and abstinence, and thus captures the net impact of treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 517

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;
Available to take one phone call per week;
Not currently interested in quitting smoking (defined as would not like to try to quit in the next 30 days),
Plans to remain in the intervention catchment area for at least 12 months
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 a 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.
Study candidate reports having a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1, Nicotine Patch, Nicotine Gum, Reduction, MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
1, Nicotine Patch, Nicotine Gum, Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
2, Nicotine Patch, Nicotine Gum, Reduction, No MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
3, Nicotine Patch, Nicotine Gum, No Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
5, Nicotine Patch, No Nicotine Gum, Reduction, MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
5, Nicotine Patch, No Nicotine Gum, Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
6, Nicotine Patch, No Nicotine Gum, Reduction, No MI	Nicotine Patch	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
6, Nicotine Patch, No Nicotine Gum, Reduction, No MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
7, Nicotine Patch, No Nicotine Gum, No Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
9, No Nicotine Patch, Nicotine Gum, Reduction, MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
9, No Nicotine Patch, Nicotine Gum, Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
10, No Nicotine Patch, Nicotine Gum, Reduction, No MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
11, No Nicotine Patch, Nicotine Gum, No Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
13, No Nicotine Patch, No Nicotine Gum, Reduction, MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
13, No Nicotine Patch, No Nicotine Gum, Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI	Motivational Interviewing	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI	Smoking Reduction	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI	No Intervention	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
9, No Nicotine Patch, Nicotine Gum, Reduction, MI	Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
11, No Nicotine Patch, Nicotine Gum, No Reduction, MI	Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
5, Nicotine Patch, No Nicotine Gum, Reduction, MI	Nicotine Patch	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
7, Nicotine Patch, No Nicotine Gum, No Reduction, MI	Nicotine Patch	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI	Nicotine Patch	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
10, No Nicotine Patch, Nicotine Gum, Reduction, No MI	Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI	Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)
1, Nicotine Patch, Nicotine Gum, Reduction, MI	Nicotine Patch + Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)
2, Nicotine Patch, Nicotine Gum, Reduction, No MI	Nicotine Patch + Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)
3, Nicotine Patch, Nicotine Gum, No Reduction, MI	Nicotine Patch + Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)
4, Nicotine Patch, Nicotine Gum, No Reduction, No MI	Nicotine Patch + Nicotine Gum	This arm of the project will address the following question: How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)

Primary Outcome Measures

Name	Time	Method
Percent Change in Cigarettes Smoked Per Day (CPD)	Assessed at week 26 relative to baseline CPD.	Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model. Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces "average number of cigarettes per day in the past week" (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar.

Secondary Outcome Measures

Name	Time	Method
Average Number of Cigarettes Per Day in the Past Week.	Assessed at baseline and week 26.

Trial Locations

Locations (1): University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
🇺🇸
Madison, Wisconsin, United States