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| ID | Type | Description | Link |
|---|---|---|---|
| A534252 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\TOBACCO RE | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Penn State University | OTHER |
| University of Illinois at Chicago | OTHER |
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | 8 weeks of nicotine patch |
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| in-person counseling and quitline counseling |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Piper, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30212849 | Result | 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. | |
| 39868569 | Derived | 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. |
| Label | URL |
|---|---|
| Description: University of Wisconsin Center for Tobacco Research and Intervention | View source |
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Primary care patients who passed the phone screen were invited to attend a study visit at their referring clinic to learn more about the study, have eligibility confirmed, and provide written informed consent. No enrolled participants were excluded from the study prior to assignment to groups.
Participants were patients from seven primary care clinics within two Wisconsin healthcare systems. Smokers who expressed interest in quitting smoking during a clinic visit were referred via the electronic health record (EHR) to the research study. Other smokers from these clinics were recruited via mailings and EHR messaging.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2018 |
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| Behavioral |
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 |
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| Preparation Nicotine Mini-Lozenges | Drug | Nicotine lozenge prior to attempting to quit smoking |
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| Combination NRT (nicotine patch + nicotine mini-lozenges) | Drug | 26 weeks of combination NRT as part of a quit smoking attempt |
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| Intensive In-Person Cessation Counseling | Behavioral | three 20-min In-person Cessation Counseling sessions |
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| Extended Maintenance Counseling Calls | Behavioral | 8 Maintenance-phase smoking cessation counseling sessions |
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| Automated Adherence Calls | Behavioral | 11 brief, automated calls reminding them to use their medications properly |
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| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | Adult smokers interested in quitting smoking who met inclusion and exclusion criteria. | Posted | Count of Participants | Participants | 6 months post treatment |
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Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 315 | 0 | 315 | 66 | 315 |
| EG001 | 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 | 0 | 308 | 0 | 308 | 139 | 308 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Itching or Hives | Immune system disorders | Systematic Assessment |
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| Sore Throat | General disorders | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Vivid Dreams | Psychiatric disorders | Systematic Assessment |
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| Hiccups | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Problem | General disorders | Systematic Assessment |
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| Persistent Indigestion | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stevens S. Smith, Ph.D. | Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health | 6082627563 | sss@ctri.wisc.edu |
| Mar 5, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2014 | Mar 5, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
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| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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