SmokingPhase 4MotivationNCT01122238
Identifying Treatments to Motivate Smokers to Quit
A Phase 4 study testing Nicotine Patch, Nicotine Gum and Motivational Interviewing in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Smoking, Smoking Cessation, Motivation
- What is being tested?
- Nicotine Patch, Nicotine Gum and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711-2027
About this study
Official title: Identifying Optimal, Translatable Smoking Cessation Intervention Components
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.
Read the 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
- Being tested
- Nicotine Patch, Nicotine Gum, Motivational Interviewing, Smoking Reduction, No Intervention
- Keywords
- Smoking, Smoking Cessation, Motivation, Nicotine Dependence
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
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.
Nicotine GumDrug
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 InterviewingBehavioural
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 ReductionBehavioural
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.
No InterventionOther
No Intervention
Nicotine Patch + Nicotine GumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at week 26 relative to baseline CPD.
Secondary outcomes (1)
Average Number of Cigarettes Per Day in the Past Week.
Measured: Assessed at baseline and week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Dean Health System, Mercy Health System, Wake Forest University Health Sciences, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael C. Fiore, MD, MPH, MBA, Study chair, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthJessica Cook, PhD, Study director, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthRobin Mermelstein, PhD, Principal investigator, Institute for Health Research and Policy, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122238
- Sponsor's protocol ID
- H-2009-0203
- Other IDs
- 9P50CA143188
- Acronym
- Motivation
- Status last verified
- Nov 2015
- First submitted
- 7 May 2010
- Last updated
- 16 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37335995
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Optimal, Translatable Smoking Cessation Intervention Components
- ClinicalTrials.gov ID
- NCT01122238
- Acronym / sponsor ID
- Motivation / H-2009-0203
- Conditions
- Smoking, Smoking Cessation, Motivation, Nicotine Dependence
- Keywords
- Smoking, Smoking Cessation, Motivation, Nicotine Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Dean Health System, Mercy Health System, Wake Forest University Health Sciences, National Cancer Institute (NCI)
- Study start
- Jun 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| 1, Nicotine Patch, Nicotine Gum, Reduction, MI | Experimental | Behavioral: Motivational Interviewing, Behavioral: Smoking Reduction, Drug: Nicotine Patch + Nicotine GumThis 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 | Experimental | Behavioral: Motivational Interviewing, Drug: Nicotine Patch + Nicotine GumThis 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 | Experimental | Behavioral: Smoking Reduction, Drug: Nicotine Patch + Nicotine GumThis 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 | Experimental | Drug: Nicotine Patch + Nicotine GumThis 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) |
| 5, Nicotine Patch, No Nicotine Gum, Reduction, MI | Experimental | Drug: Nicotine Patch, Behavioral: Motivational Interviewing, Behavioral: Smoking ReductionThis 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 | Experimental | Drug: Nicotine Patch, Behavioral: Motivational InterviewingThis 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 | Experimental | Drug: Nicotine Patch, Behavioral: Smoking ReductionThis 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 | Experimental | Drug: Nicotine PatchThis 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) |
| 9, No Nicotine Patch, Nicotine Gum, Reduction, MI | Experimental | Drug: Nicotine Gum, Behavioral: Motivational Interviewing, Behavioral: Smoking ReductionThis 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 | Experimental | Drug: Nicotine Gum, Behavioral: Motivational InterviewingThis 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 | Experimental | Drug: Nicotine Gum, Behavioral: Smoking ReductionThis 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) |
| 12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI | Experimental | Drug: Nicotine GumThis 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) |
| 13, No Nicotine Patch, No Nicotine Gum, Reduction, MI | Experimental | Behavioral: Motivational Interviewing, Behavioral: Smoking ReductionThis 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 | Experimental | Behavioral: Motivational InterviewingThis 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 | Experimental | Behavioral: Smoking ReductionThis 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 | Experimental | Other: No InterventionThis 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine PatchIf 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. | Drug | 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 GumIf 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. | Drug | 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 InterviewingParticipants 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. | Behavioural | 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 ReductionParticipants 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. | Behavioural | 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 InterventionNo Intervention | Other | 16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI |
| Nicotine Patch + Nicotine GumIf 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. | Drug | 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 |
Primary outcome
Percent Change in Cigarettes Smoked Per Day (CPD)
Time frame: 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.
1 secondary outcome
Average Number of Cigarettes Per Day in the Past Week.
Time frame: Assessed at baseline and week 26.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37335995Theodoulou 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.
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C. Fiore, MD, MPH, MBA study chair
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Jessica Cook, PhD study director
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Robin Mermelstein, PhD principal investigator
Institute for Health Research and Policy, University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Patch, Nicotine Gum and Motivational Interviewing in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Cigarettes Smoked Per Day (CPD) (time frame: Assessed at week 26 relative to baseline CPD.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.