Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 9P50CA143188 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| Dean Health System | OTHER |
| Mercy Health System | NETWORK |
| Wake Forest University Health Sciences |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Cigarettes Per Day in the Past Week. | Assessed at baseline and week 26. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711-2027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37335995 | Derived | 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. |
| Label | URL |
|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| FG005 | 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) |
| FG006 | 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) |
| FG007 | 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) |
| FG008 | 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) |
| FG009 | 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) |
| FG010 | 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) |
| FG011 | 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) |
| FG012 | 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) |
| FG013 | 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) |
| FG014 | 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) |
| FG015 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult smokers who consented to enroll in the treatment study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 2, Nicotine Patch, Nicotine Gum, Reduction, No MI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Average Number of Cigarettes Per Day in the Past Week. | Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals. | Posted | Mean | Standard Deviation | Change in cigarettes per day | Assessed at baseline and week 26. |
|
AEs were reported weekly for the 6 weeks study subjects were on medication.
Data from ad Hoc AE reports and protocol prompted weekly AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prequit Combined Nicotine Patch + Gum | Prequit Combined Nicotine Patch + Gum Participants randomized to this condition received 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment | specific Adverse Event Terms are unknown because adverse events were only collected with regard to the affected organ system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stevens Smith | UWisconsin | 608-262-7563 | sss@ctri.medicine.wisc.edu |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 |
Not provided
Not provided
| OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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. |
|
| 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. |
|
| 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. |
|
| No Intervention | Other | No Intervention |
|
| 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. |
|
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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | 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) |
| BG006 | 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) |
| BG007 | 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) |
| BG008 | 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) |
| BG009 | 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) |
| BG010 | 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) |
| BG011 | 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) |
| BG012 | 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) |
| BG013 | 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) |
| BG014 | 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) |
| BG015 | 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) |
| BG016 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Nicotine Patch | All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison. |
| OG002 | Nicotine Gum | All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison. |
| OG003 | No Nicotine Gum | All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison. |
| OG004 | Smoking Reduction | All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison. |
| OG005 | No Smoking Reduction | All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison. |
| OG006 | Motivational Interviewing | All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison. |
| OG007 | No Motivational Interviewing | All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison. |
|
|
|
| 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. | Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals. | Posted | Mean | Standard Deviation | Percent Change in cigarettes per day | Assessed at week 26 relative to baseline CPD. |
|
|
|
|
| 2 |
| 133 |
| 71 |
| 133 |
| EG001 | Prequit Nicotine Patch Only | Prequit Nicotine Patch Only Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks. | 1 | 132 | 67 | 132 |
| EG002 | Prequit Nicotine Gum Only | Prequit Nicotine Gum Only. Participants randomized to this condition received 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. | 3 | 131 | 33 | 131 |
| EG003 | No Medication | No Medication Participants randomized to this condition received no medication. | 2 | 121 | 0 | 121 |
|
| Death-unknown cause | General disorders | Non-systematic Assessment | specific Adverse Event Terms are unknown because adverse events were only collected with regard to the affected organ system |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | specific Adverse Event Terms are unknown because adverse events were only collected with regard to the affected organ system |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | specific Adverse Event Terms are unknown because adverse events were only collected with regard to the affected organ system |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Irregular Heartbeat | Cardiac disorders | Systematic Assessment |
|
| Itches or Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mouth Problems | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| VividDreams | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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. |
| Regression, Linear |
| .40 |
| Standardized Regression Coefficient |
| -.04 |
| 2-Sided |
| No |
| Superiority or Other |
| 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. | Regression, Linear | .99 | Standardized Regression Coefficient | -.00 | 2-Sided | No | Superiority or Other |
| 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. | Regression, Linear | .33 | Standardized Regression Coefficient | -.04 | 2-Sided | No | Superiority or Other |