A Comparative Effectiveness RCT of Optimized Cessation Treatments
NCT ID: NCT02301403
Last Updated: 2020-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
623 participants
INTERVENTIONAL
2015-01-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modern Usual Care
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch
8 weeks of nicotine patch
in-person counseling and quitline counseling
a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges
Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges)
26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling
three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls
8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls
11 brief, automated calls reminding them to use their medications properly
Interventions
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Nicotine patch
8 weeks of nicotine patch
in-person counseling and quitline counseling
a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
Preparation Nicotine Mini-Lozenges
Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges)
26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling
three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls
8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls
11 brief, automated calls reminding them to use their medications properly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Penn State University
OTHER
University of Illinois at Chicago
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Megan Piper, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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References
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Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Description: University of Wisconsin Center for Tobacco Research and Intervention
Other Identifiers
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A534252
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\TOBACCO RE
Identifier Type: OTHER
Identifier Source: secondary_id
2014-1041 Cessation
Identifier Type: -
Identifier Source: org_study_id
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