Clinical trial NCT01122238
Conditions: Smoking Smoking Cessation Motivation Nicotine Dependence
Keywords: Smoking Smoking Cessation Motivation Nicotine Dependence
Sponsor: University of Wisconsin, Madison
Start date: 2010-06-01; Completion date: 2014-05-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

Arms: arm 1: 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) arm 2: 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) arm 3: 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) arm 4: 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) arm 5: 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) arm 6: 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) arm 7: 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) arm 8: 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) arm 9: 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) arm 10: 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) arm 11: 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) arm 12: 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) arm 13: 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) arm 14: 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) arm 15: 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) arm 16: 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)
Interventions: intervention 1: Nicotine Patch intervention 2: Nicotine Gum intervention 3: Motivational Interviewing intervention 4: Smoking Reduction intervention 5: No Intervention intervention 6: Nicotine Patch + Nicotine Gum
Intervention descriptions: intervention 1: If randomized to only the Nicotine Patch condition (and not the Nicotine Gum):

Participants randomized to this condition will receive a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks. intervention 2: If randomized to only the Nicotine Gum condition (and not the Nicotine Patch):

Participants randomized to this condition will receive a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks. intervention 3: Participants randomized to this condition will receive an initial MI counseling session during the in-person clinic visit followed by three counseling phone calls over the 6-week intervention period (a total of four intervention contacts). The phone counseling sessions will occur during weeks 2, 4, and 6. Case managers will engage the participant in a series of motivation building exercises such as reviewing feelings and thoughts about the pros and cons of quitting and smoking, reinforcing the positives of quitting, helping to dispel myths and concerns about the negatives of quitting, and posing questions about the "good" aspects of smoking. intervention 4: Participants randomized to Smoking Reduction will receive an initial counseling session during the in-person visit followed by 6 weekly phone counseling sessions over the 6-week intervention period. During the initial session, participants will be told that the goal is to reduce cigarette consumption by 50% over the course of the intervention (approximately 10% reduction per week). During the initial meeting and subsequent counseling calls, case managers will work with participants to problem-solve strategies for reduction (e.g., increasing time between cigarettes, delaying smoking, or eliminating smoking in specific situations). Participants will be asked to record information in a provided smoking log to help keep track of daily smoking patterns and as a feedback mechanism for identifying successes and challenges. intervention 5: No Intervention intervention 6: If randomized to both the Nicotine Patch and the Nicotine Gum conditions:

Participants randomized to this condition will receive a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks.

Protocol documents: