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Identifying Treatments to Motivate Smokers to Quit

Identifying Optimal, Translatable Smoking Cessation Intervention Components

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01122238
Acronym
Motivation
Enrollment
517
Registered
2010-05-13
Start date
2010-06-30
Completion date
2014-05-31
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motivation, Nicotine Dependence, Smoking, Smoking Cessation

Keywords

Smoking, Smoking Cessation, Motivation, Nicotine Dependence

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.

Interventions

DRUGNicotine 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.

DRUGNicotine 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.

BEHAVIORALMotivational 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.

BEHAVIORALSmoking 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.

OTHERNo Intervention

No Intervention

DRUGNicotine 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.

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
Dean Health System
CollaboratorOTHER
Mercy Health System
CollaboratorNETWORK
Wake Forest University Health Sciences
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frame
Average Number of Cigarettes Per Day in the Past Week.Assessed at baseline and week 26.

Countries

United States

Participant flow

Participants by arm

ArmCount
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)
30
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)
37
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)
33
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)
33
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)
33
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)
32
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)
35
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)
32
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)
32
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)
34
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)
32
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)
33
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)
30
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)
32
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)
28
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)
31
Total517

Baseline characteristics

Characteristic2, Nicotine Patch, Nicotine Gum, Reduction, No MI3, Nicotine Patch, Nicotine Gum, No Reduction, MI4, Nicotine Patch, Nicotine Gum, No Reduction, No MI5, Nicotine Patch, No Nicotine Gum, Reduction, MI6, Nicotine Patch, No Nicotine Gum, Reduction, No MI7, Nicotine Patch, No Nicotine Gum, No Reduction, MI8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI9, No Nicotine Patch, Nicotine Gum, Reduction, MI1, Nicotine Patch, Nicotine Gum, Reduction, MI10, No Nicotine Patch, Nicotine Gum, Reduction, No MI11, No Nicotine Patch, Nicotine Gum, No Reduction, MI12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI13, No Nicotine Patch, No Nicotine Gum, Reduction, MI14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MITotal
Age, Categorical
<=18 years
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants0 Participants0 Participants6 Participants
Age, Categorical
>=65 years
3 Participants5 Participants7 Participants1 Participants2 Participants4 Participants3 Participants3 Participants1 Participants4 Participants4 Participants2 Participants5 Participants4 Participants6 Participants5 Participants59 Participants
Age, Categorical
Between 18 and 65 years
34 Participants27 Participants26 Participants32 Participants30 Participants30 Participants28 Participants29 Participants29 Participants30 Participants26 Participants31 Participants25 Participants27 Participants22 Participants26 Participants452 Participants
Age, Continuous46.00 years
STANDARD_DEVIATION 14.05
49.18 years
STANDARD_DEVIATION 14.89
48.91 years
STANDARD_DEVIATION 13.22
47.00 years
STANDARD_DEVIATION 14.03
48.47 years
STANDARD_DEVIATION 14.5
44.89 years
STANDARD_DEVIATION 14.57
47.91 years
STANDARD_DEVIATION 14.19
41.63 years
STANDARD_DEVIATION 15.4
44.37 years
STANDARD_DEVIATION 13.28
49.53 years
STANDARD_DEVIATION 13.77
45.41 years
STANDARD_DEVIATION 14.89
47.30 years
STANDARD_DEVIATION 13.9
46.87 years
STANDARD_DEVIATION 14.71
47.06 years
STANDARD_DEVIATION 14.98
51.93 years
STANDARD_DEVIATION 12.82
46.84 years
STANDARD_DEVIATION 15.18
47.05 years
STANDARD_DEVIATION 14.33
Region of Enrollment
United States
37 participants33 participants33 participants33 participants32 participants35 participants32 participants32 participants30 participants34 participants32 participants33 participants30 participants32 participants28 participants31 participants517 participants
Sex: Female, Male
Female
24 Participants20 Participants21 Participants21 Participants19 Participants23 Participants21 Participants20 Participants19 Participants21 Participants21 Participants22 Participants18 Participants21 Participants18 Participants19 Participants328 Participants
Sex: Female, Male
Male
13 Participants13 Participants12 Participants12 Participants13 Participants12 Participants11 Participants12 Participants11 Participants13 Participants11 Participants11 Participants12 Participants11 Participants10 Participants12 Participants189 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
71 / 13367 / 13233 / 1310 / 121
serious
Total, serious adverse events
2 / 1331 / 1323 / 1312 / 121

Outcome results

Primary

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.

Time frame: Assessed at week 26 relative to baseline CPD.

Population: Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.

ArmMeasureValue (MEAN)Dispersion
Nicotine PatchPercent Change in Cigarettes Smoked Per Day (CPD)38.7 Percent Change in cigarettes per dayStandard Deviation 36.2
No Nicotine PatchPercent Change in Cigarettes Smoked Per Day (CPD)38.9 Percent Change in cigarettes per dayStandard Deviation 37.1
Nicotine GumPercent Change in Cigarettes Smoked Per Day (CPD)37.4 Percent Change in cigarettes per dayStandard Deviation 36.2
No Nicotine GumPercent Change in Cigarettes Smoked Per Day (CPD)40.2 Percent Change in cigarettes per dayStandard Deviation 36.9
Smoking ReductionPercent Change in Cigarettes Smoked Per Day (CPD)38.6 Percent Change in cigarettes per dayStandard Deviation 36.3
No Smoking ReductionPercent Change in Cigarettes Smoked Per Day (CPD)38.9 Percent Change in cigarettes per dayStandard Deviation 36.9
Motivational InterviewingPercent Change in Cigarettes Smoked Per Day (CPD)37.2 Percent Change in cigarettes per dayStandard Deviation 35.6
No Motivational InterviewingPercent Change in Cigarettes Smoked Per Day (CPD)40.2 Percent Change in cigarettes per dayStandard Deviation 37.5
Comparison: The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.p-value: 0.98Regression, Linear
Comparison: The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.p-value: 0.4Regression, Linear
Comparison: The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.p-value: 0.99Regression, Linear
Comparison: The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.p-value: 0.33Regression, Linear
Secondary

Average Number of Cigarettes Per Day in the Past Week.

Time frame: Assessed at baseline and week 26.

Population: Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.

ArmMeasureValue (MEAN)Dispersion
Nicotine PatchAverage Number of Cigarettes Per Day in the Past Week..117 Change in cigarettes per dayStandard Deviation 6.688
No Nicotine PatchAverage Number of Cigarettes Per Day in the Past Week.-.123 Change in cigarettes per dayStandard Deviation 6.54
Nicotine GumAverage Number of Cigarettes Per Day in the Past Week..179 Change in cigarettes per dayStandard Deviation 6.402
No Nicotine GumAverage Number of Cigarettes Per Day in the Past Week.-.187 Change in cigarettes per dayStandard Deviation 6.83
Smoking ReductionAverage Number of Cigarettes Per Day in the Past Week.-.158 Change in cigarettes per dayStandard Deviation 6.568
No Smoking ReductionAverage Number of Cigarettes Per Day in the Past Week..160 Change in cigarettes per dayStandard Deviation 6.663
Motivational InterviewingAverage Number of Cigarettes Per Day in the Past Week..371 Change in cigarettes per dayStandard Deviation 6.597
No Motivational InterviewingAverage Number of Cigarettes Per Day in the Past Week.-.353 Change in cigarettes per dayStandard Deviation 6.617
Comparison: The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.p-value: 0.665ANCOVA
Comparison: The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.p-value: 0.562ANCOVA
Comparison: The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.p-value: 0.536ANCOVA
Comparison: The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.p-value: 0.206ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026