Identifying Treatments to Motivate Smokers to Quit
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | May 2014 |
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.
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.
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.
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.
We found this trial at
1
site
Madison, Wisconsin 53711
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