Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | January 2015 |
| End Date: | May 2019 |
Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
The ultimate goal of this research is to develop a chronic care treatment package for smokers
that will address the challenges and opportunities of each phase of the cessation process -
motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop
treatments for smokers not yet ready to quit, those who are preparing to quit, those actively
engaged in the quitting process and those who have tried to quit but relapsed. To achieve
this goal, this research comprises three distinct research studies, each of which represent a
phase in a comprehensive chronic care treatment model for clinical intervention with smokers
in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term
Quitting Study. The goal of each study is to test and identify effective intervention
components for distinct phases of the smoking cessation process. These components will then
be combined for future research on the effectiveness of this chronic care treatment package.
This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two
levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral
Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs
Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4)
Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling.
These components have strong theoretical and empirical support, but their relative, additive,
and interactive effects are unknown.
that will address the challenges and opportunities of each phase of the cessation process -
motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop
treatments for smokers not yet ready to quit, those who are preparing to quit, those actively
engaged in the quitting process and those who have tried to quit but relapsed. To achieve
this goal, this research comprises three distinct research studies, each of which represent a
phase in a comprehensive chronic care treatment model for clinical intervention with smokers
in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term
Quitting Study. The goal of each study is to test and identify effective intervention
components for distinct phases of the smoking cessation process. These components will then
be combined for future research on the effectiveness of this chronic care treatment package.
This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two
levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral
Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs
Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4)
Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling.
These components have strong theoretical and empirical support, but their relative, additive,
and interactive effects are unknown.
Inclusion Criteria:
- age >=18 years; smoking >4 cigarettes/day for the previous 6 months; able to read,
write, and speak English; have reliable phone access and agree to respond to
Interactive Voice Response (IVR) phone prompts; and if currently using NRT, agreeing
to use only study medication for the duration of the study. We will not exclude
participants based on their prior use of cessation medication or if they use multiple
tobacco products in order to enhance real-world generalization (these will be
statistically controlled in analyses); not currently attempting to quit smoking; not
intending to quit smoking (defined as no plans to quit in the next month); and
planning to remain in the intervention catchment area for at least 12 months.
Exclusion Criteria:
- currently taking bupropion or varenicline; medical contraindications to using NRT
including hospitalized (for at least one night) for a stroke, heart attack, congestive
heart failure or diabetes in the last 30 days; diagnosis of or treatment for
schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years; and, if
the participant is a woman of childbearing potential, being pregnant or intending to
becoming pregnant or unwillingness to use an approved method of birth control during
treatment.
We found this trial at
1
site
Madison, Wisconsin 53711
Phone: 608-265-9775
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