Clinical trial NCT02354872: Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
Official title: Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Motivation
Smoking Cessation
Keywords: Nicotine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of Illinois at Chicago
name: National Cancer Institute (NCI)
First posted: 2015-02-03
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 7-Day Point-Prevalence Abstinence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Michael C Fiore, MD, MPH, MBA
role: STUDY_CHAIR
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Jessica Cook, PhD
role: STUDY_DIRECTOR
affiliation: Institute for Health Research and Policy, University of Illinois at Chicago
name: Robin Mermelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cook JW, Baker TB, Fiore MC, Collins LM, Piper ME, Schlam TR, Bolt DM, Smith SS, Zwaga D, Jorenby DE, Mermelstein R. Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment. Addiction. 2021 Nov;116(11):3167-3179. doi: 10.1111/add.15528. Epub 2021 May 19.