Smoking CessationPhase 4NCT02301403
A Comparative Effectiveness RCT of Optimized Cessation Treatments
A Phase 4 study testing Nicotine patch, in-person counseling and quitline counseling and Preparation Nicotine Mini-Lozenges in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 Cessation Treatment (AOCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch, in-person counseling and quitline counseling and Preparation Nicotine Mini-Lozenges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 623 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Feb 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711
About this study
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 Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.
Read the 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, 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
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, in-person counseling and quitline counseling, Preparation Nicotine Mini-Lozenges, Combination NRT (nicotine patch + nicotine mini-lozenges), Intensive In-Person Cessation Counseling
- Keywords
- smoking, cessation, tobacco
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
8 weeks of nicotine patch
in-person counseling and quitline counselingBehavioural
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-LozengesDrug
Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges)Drug
26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation CounselingBehavioural
three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling CallsBehavioural
8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence CallsBehavioural
11 brief, automated calls reminding them to use their medications properly
| Study group | Role | What they receive |
|---|---|---|
| Modern Usual Care | Active comparator | 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). Receives: Drug: Nicotine patch; Behavioral: in-person counseling and quitline counseling |
| Abstinence-Optimized Cessation Treatment | Experimental | 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. Receives: Drug: Preparation Nicotine Mini-Lozenges; Drug: Combination NRT (nicotine patch + nicotine mini-lozenges); Behavioral: Intensive In-Person Cessation Counseling; Behavioral: Extended Maintenance Counseling Calls; Behavioral: Automated Adherence Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abstinence From Smoking
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide < 6 parts per million).
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- Megan Piper, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301403
- Sponsor's protocol ID
- 2014-1041 Cessation
- Other IDs
- A534252, SMPH\MEDICINE\TOBACCO RE
- Status last verified
- May 2020
- First submitted
- 21 Nov 2014
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 30212849Theodoulou 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.
PubMed 39868569
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness RCT of Optimized Cessation Treatments
- ClinicalTrials.gov ID
- NCT02301403
- Acronym / sponsor ID
- 2014-1041 Cessation
- Conditions
- Smoking Cessation
- Keywords
- smoking, cessation, tobacco
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Penn State University, University of Illinois Chicago
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 25 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.
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, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modern Usual Care | Active comparator | Drug: Nicotine patch, Behavioral: in-person counseling and quitline counselingParticipants 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). |
| Abstinence-Optimized Cessation Treatment | Experimental | Drug: Preparation Nicotine Mini-Lozenges, Drug: Combination NRT (nicotine patch + nicotine mini-lozenges), Behavioral: Intensive In-Person Cessation Counseling, Behavioral: Extended Maintenance Counseling Calls, Behavioral: Automated Adherence CallsThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patch8 weeks of nicotine patch | Drug | Modern Usual Care |
| in-person counseling and quitline counselinga 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 | Behavioural | Modern Usual Care |
| Preparation Nicotine Mini-LozengesNicotine lozenge prior to attempting to quit smoking | Drug | Abstinence-Optimized Cessation Treatment |
| Combination NRT (nicotine patch + nicotine mini-lozenges)26 weeks of combination NRT as part of a quit smoking attempt | Drug | Abstinence-Optimized Cessation Treatment |
| Intensive In-Person Cessation Counselingthree 20-min In-person Cessation Counseling sessions | Behavioural | Abstinence-Optimized Cessation Treatment |
| Extended Maintenance Counseling Calls8 Maintenance-phase smoking cessation counseling sessions | Behavioural | Abstinence-Optimized Cessation Treatment |
| Automated Adherence Calls11 brief, automated calls reminding them to use their medications properly | Behavioural | Abstinence-Optimized Cessation Treatment |
Primary outcome
Number of Participants With Abstinence From Smoking
Time frame: 6 months post treatment
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide < 6 parts per million).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30212849Piper 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.
- Derived from this study: PubMed 39868569Theodoulou 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.
- Description: University of Wisconsin Center for Tobacco Research and InterventionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Piper, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch, in-person counseling and quitline counseling and Preparation Nicotine Mini-Lozenges in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Abstinence From Smoking (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020; AzTrials last refreshed its copy on 4 Nov 2026.