Status:
COMPLETED
A Comparative Effectiveness RCT of Optimized Cessation Treatments
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Penn State University
University of Illinois at Chicago
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Ces...
Detailed Description
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, pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT02301403
Start Date
January 1 2015
End Date
February 1 2018
Last Update
May 13 2020
Active Locations (1)
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1
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711