Identifying Treatments to Motivate Smokers to Quit

NCT01122238 | Completed Phase 4 Results DMC

• 2 other identifiers: H-2009-02039P50CA143188
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation; Motivation; Nicotine Dependence

Keywords

Smoking; Smoking Cessation; Motivation; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Percent Change in Cigarettes Smoked Per Day (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.

  Assessed at week 26 relative to baseline CPD.

Secondary Outcomes (1)

• Average Number of Cigarettes Per Day in the Past Week.

  Assessed at baseline and week 26.

Study Arms (16)

1, Nicotine Patch, Nicotine Gum, Reduction, MI

EXPERIMENTAL

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)

Behavioral: Motivational Interviewing; Behavioral: Smoking Reduction; Drug: Nicotine Patch + Nicotine Gum

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

EXPERIMENTAL

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)

Behavioral: Motivational Interviewing; Drug: Nicotine Patch + Nicotine Gum

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

EXPERIMENTAL

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)

Behavioral: Smoking Reduction; Drug: Nicotine Patch + Nicotine Gum

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

EXPERIMENTAL

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)

Drug: Nicotine Patch + Nicotine Gum

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

EXPERIMENTAL

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)

Drug: Nicotine Patch; Behavioral: Motivational Interviewing; Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Drug: Nicotine Patch; Behavioral: Motivational Interviewing

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

EXPERIMENTAL

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)

Drug: Nicotine Patch; Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Drug: Nicotine Patch

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

EXPERIMENTAL

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)

Drug: Nicotine Gum; Behavioral: Motivational Interviewing; Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Drug: Nicotine Gum; Behavioral: Motivational Interviewing

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

EXPERIMENTAL

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)

Drug: Nicotine Gum; Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Drug: Nicotine Gum

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

EXPERIMENTAL

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)

Behavioral: Motivational Interviewing; Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Behavioral: Motivational Interviewing

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

EXPERIMENTAL

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)

Behavioral: Smoking Reduction

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

EXPERIMENTAL

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)

Other: No Intervention

Interventions

Nicotine Patch 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.

5, Nicotine Patch, No Nicotine Gum, Reduction, MI; 6, Nicotine Patch, No Nicotine Gum, Reduction, No MI; 7, Nicotine Patch, No Nicotine Gum, No Reduction, MI; 8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI

Nicotine Gum 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.

10, No Nicotine Patch, Nicotine Gum, Reduction, No MI; 11, No Nicotine Patch, Nicotine Gum, No Reduction, MI; 12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI; 9, No Nicotine Patch, Nicotine Gum, Reduction, MI

Motivational Interviewing 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.

1, Nicotine Patch, Nicotine Gum, Reduction, MI; 10, No Nicotine Patch, Nicotine Gum, Reduction, No MI; 13, No Nicotine Patch, No Nicotine Gum, Reduction, MI; 14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI; 2, Nicotine Patch, Nicotine Gum, Reduction, No MI; 5, Nicotine Patch, No Nicotine Gum, Reduction, MI; 6, Nicotine Patch, No Nicotine Gum, Reduction, No MI; 9, No Nicotine Patch, Nicotine Gum, Reduction, MI

Smoking Reduction 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.

1, Nicotine Patch, Nicotine Gum, Reduction, MI; 11, No Nicotine Patch, Nicotine Gum, No Reduction, MI; 13, No Nicotine Patch, No Nicotine Gum, Reduction, MI; 15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI; 3, Nicotine Patch, Nicotine Gum, No Reduction, MI; 5, Nicotine Patch, No Nicotine Gum, Reduction, MI; 7, Nicotine Patch, No Nicotine Gum, No Reduction, MI; 9, No Nicotine Patch, Nicotine Gum, Reduction, MI

No Intervention OTHER

No Intervention

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

Nicotine Patch + Nicotine Gum 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.

1, Nicotine Patch, Nicotine Gum, Reduction, MI; 2, Nicotine Patch, Nicotine Gum, Reduction, No MI; 3, Nicotine Patch, Nicotine Gum, No Reduction, MI; 4, Nicotine Patch, Nicotine Gum, No Reduction, No MI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Illinois at Chicago: collaborator
• Dean Health System: collaborator
• Mercy Health System: collaborator
• Wake Forest University Health Sciences: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Madison, Wisconsin, 53711-2027, United States

Location

Related Publications (1)

• 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.

  PMID: 37335995 DERIVED

Related Links

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

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Stevens Smith
• Organization: UWisconsin

sss@ctri.medicine.wisc.edu

608-262-7563

Study Officials

• Michael C. Fiore, MD, MPH, MBA

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

  STUDY CHAIR

• Jessica Cook, PhD

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

  STUDY DIRECTOR

• Robin Mermelstein, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 13, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 16, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-11

Locations

US (1)