Identifying Treatments to Motivate Smokers to Quit

NCT ID: NCT01122238

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Smoking; Smoking Cessation; Motivation; Nicotine Dependence

Keywords

Smoking; Smoking Cessation; Motivation; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1, Nicotine Patch, Nicotine Gum, Reduction, MI

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)

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

Nicotine Patch + Nicotine Gum

Intervention Type: DRUG

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.

2, Nicotine Patch, Nicotine Gum, Reduction, No MI

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)

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Nicotine Patch + Nicotine Gum

Intervention Type: DRUG

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.

3, Nicotine Patch, Nicotine Gum, No Reduction, MI

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)

Group Type: EXPERIMENTAL

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

Nicotine Patch + Nicotine Gum

Intervention Type: DRUG

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.

4, Nicotine Patch, Nicotine Gum, No Reduction, No MI

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)

Group Type: EXPERIMENTAL

Nicotine Patch + Nicotine Gum

Intervention Type: DRUG

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.

5, Nicotine Patch, No Nicotine Gum, Reduction, MI

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)

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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.

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

6, Nicotine Patch, No Nicotine Gum, Reduction, No MI

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)

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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.

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

7, Nicotine Patch, No Nicotine Gum, No Reduction, MI

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)

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI

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)

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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.

9, No Nicotine Patch, Nicotine Gum, Reduction, MI

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)

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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.

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

10, No Nicotine Patch, Nicotine Gum, Reduction, No MI

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)

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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.

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

11, No Nicotine Patch, Nicotine Gum, No Reduction, MI

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)

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI

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)

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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.

13, No Nicotine Patch, No Nicotine Gum, Reduction, MI

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)

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI

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)

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI

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)

Group Type: EXPERIMENTAL

Smoking Reduction

Intervention Type: BEHAVIORAL

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.

16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI

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)

Group Type: EXPERIMENTAL

No Intervention

Intervention Type: OTHER

No Intervention

Interventions

Nicotine Patch

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 Type: DRUG

Nicotine Gum

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 Type: DRUG

Motivational Interviewing

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 Type: BEHAVIORAL

Smoking Reduction

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 Type: BEHAVIORAL

No Intervention

No Intervention

Intervention Type: OTHER

Nicotine Patch + Nicotine Gum

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.

Intervention Type: DRUG

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Dean Health System

OTHER

Sponsor Role: collaborator

Mercy Health System

NETWORK

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael C. Fiore, MD, MPH, MBA

Role: STUDY_CHAIR

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

Jessica Cook, PhD

Role: STUDY_DIRECTOR

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

Robin Mermelstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Health Research and Policy, University of Illinois at Chicago

Locations

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

Madison, Wisconsin, United States

Countries

United States

References

Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

Reference Type: DERIVED

PMID: 37335995 (View on PubMed)

Related Links

http://www.ctri.wisc.edu/

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

Other Identifiers

9P50CA143188

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-2009-0203

Identifier Type: -

Identifier Source: org_study_id