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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 11/18/2020 | Other Identifier | UW Madison | |
| 1R01CA218156-01 | U.S. NIH Grant/Contract | View source | |
| A534252 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\TOBACCO RE | Other Identifier | UW Madison | |
| UW20069 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| George Washington University | OTHER |
| Consumer Wellness Solutions | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. These strategies include: increasing the intensity of nicotine replacement medication (among those medically cleared to use such medications), increasing the intensity of WTQL counseling, helping callers enroll in an evidence-based smoking cessation texting support program (SmokefreeTXT), and offering moderate financial incentives for engagement in counseling and SmokefreeTXT.
This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. The four factors (strategies) to be studied include: (1) Quit line counseling intensity (1 vs 4 proactive calls); (2) Nicotine replacement therapy (NRT) intensity (Patch for 2 weeks vs Patch+Lozenge for 4 weeks); (3) SmokefreeTXT text messages (proactive enrollment vs none); and (4) financial incentives for treatment engagement (vs none). The study design is a fully-crossed 4-factor factorial design. The primary aim is: Assessment of the main and interactive effects of the four treatment factors on biochemically-confirmed 7-day point-prevalence abstinence at the 6-month followup. Secondary aims include testing: (1) self-reported abstinence at 12 weeks post-quit; (2) continuous abstinence between 1 and 6 months; (3) cost-effectiveness; and (4) moderators of treatment engagement and mediators of treatment effectiveness on 6-month abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Call, Patch, SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement are for completing the counseling call and for staying enrolled in the SmokefreeTXT program for six weeks. |
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| 1-Call, Patch, SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-Call Quitline Counseling | Behavioral | The 1-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 1 proactive call using a standard, evidence-based protocol lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point-Prevalence Abstinence | Participants will be coded as abstinent if they self-report no smoking for the past 7 days at the assessment endpoint (6 month follow-up) and provide a saliva sample for cotinine testing with a value of <4 ng/ml. Participants will be considered not abstinent if they are lost to follow-up, report any smoking in the past 7 days, return a saliva sample with cotinine greater than or equal to 4 ng/ml, or fail to return a usable saliva sample. | 6-months |
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Inclusion Criteria:
Exclusion Criteria:
1. Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Danielle E. McCarthy, PhD | University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.) | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39504025 | Derived | Kaye JT, Kirsch JA, Bolt DM, Kobinsky KH, Vickerman KA, Mullis K, Fraser DL, Baker TB, Fiore MC, McCarthy DE. Tobacco Quitline Retreatment Interventions Among Adults With Socioeconomic Disadvantage: A Factorial Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443044. doi: 10.1001/jamanetworkopen.2024.43044. |
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The University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) is committed to making final research datasets available to the scientific community in a timely fashion in accord with general NIH policy. The following are the main types of data that will be generated by this grant:
In accord with Institutional Review Board (IRB) policies, the UW-CTRI will act under its own auspices as the hub for making de-identified data available. The PI will make the set of final de-identified datasets available by request from other researchers in a timely manner.
De-identified data will be available 1 year after final data collection.
Researchers who desire access to study data must submit a Data Use Proposal to the PI.
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A total of 1316 of the target 1408 participants were recruited between June 2018 and January 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement |
| FG001 | 1-Call, Patch, SmokefreeTXT, No Financial Incentive |
| 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 | Sep 20, 2022 |
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Four-factor fully-crossed factorial design
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Research staff who conduct follow-up interviews and verification will be blind to study condition and will not have access to other participant data (e.g., smoking history) prior to the end of data collection.
| 1-Call, Patch, No SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement are for completing the counseling call. |
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| 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokeFreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered. |
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| 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following: 1-Call Quitline Counseling, 4 weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. Patch treatment will consist of a 4 week supply of over-the-counter nicotine patches (21 mg if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day [TQD] and for 6 weeks following the TQD). The Financial Incentives are for completing the counseling call and for staying enrolled in the SmokefreeTXT program for 6 weeks. |
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| 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. Nicotine Patch treatment will consist of a 4-week supply of over-the-counter nicotine patches (21 mg if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); Lozenge treatment will consist of a 4-week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered. |
|
| 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). No SmokefreeTXT text messaging in support of cessation will be offered proactively. The Financial Incentives for treatment engagement are for completing the counseling call. |
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| 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 1-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. The proactive counseling call will last approximately 20 minutes. The Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered. |
|
| 4-Call, Patch, SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination:4-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). The Financial Incentives for treatment engagement are for completing each of the four counseling calls and for staying enrolled in the SmokefreeTXT program for six weeks. |
|
| 4-Call, Patch, SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to two weeks prior to the target quit day and for six weeks following the target quit day). Financial Incentives for treatment engagement will not be offered. |
|
| 4-Call, Patch, No SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will not be offered proactively. The Financial Incentives for treatment engagement are for completing each of the four counseling calls. |
|
| 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, two weeks of Nicotine Patch, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). SmokefreeTXT text messaging in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered. |
|
| 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Experimental | Participants will receive: 4-Call Quitline Counseling, 4 weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each counseling call will last approximately 20 min. Patch treatment will consist of a 4 week supply of over-the-counter (OTC) nicotine patches (21 mg for if smoking 10 or more cigarettes per day (CPD); 14 mg if smoking fewer than 10 CPD); Lozenge treatment will consist of a 4 week supply of OTC nicotine lozenges (2-mg dose for those who do not smoke within 30 min of waking; 4-mg dose for those who smoke within 30 min of waking). SmokefreeTXT in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day [TQD] and for 6 weeks following the TQD). Financial Incentives are for completing each of the 4 counseling calls and for staying enrolled in SmokefreeTXT for 6 weeks. |
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| 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, instruction in enrolling in SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Patch treatment will consist of a 4-week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); Lozenge treatment will consist of a 4-week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT in support of cessation will consist of 6-8 weeks of text messages (up to 5 messages per day for up to 2 weeks prior to the target quit day and for 6 weeks following the target quit day). Financial Incentives for treatment engagement will not be offered. |
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| 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenge, No SmokefreeTXT, and Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT text messaging in support of cessation will not be offered proactively. The Financial Incentives for treatment engagement are for completing each of the four counseling calls. |
|
| 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | Experimental | Participants will receive the following treatment combination: 4-Call Quitline Counseling, four weeks of Nicotine Patch and Nicotine Lozenges, No SmokefreeTXT, and No Financial Incentives for Treatment Engagement. Each of the proactive counseling calls will last approximately 20 minutes. The Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). SmokefreeTXT in support of cessation will not be offered proactively. Financial Incentives for treatment engagement will not be offered. |
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| 4-Call Quitline Counseling | Behavioral | The 4-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 4 proactive calls that use a standard, evidence-based protocol with each call lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available. |
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| Nicotine patch | Drug | Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD). |
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| Nicotine Patch and Nicotine Lozenge | Drug | The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); the Nicotine Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking). |
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| SmokefreeTXT | Behavioral | SmokefreeTXT support is a national program offered at no cost to users (apart from data/minute costs charged by cellular providers about which enrollees are advised at enrollment) and is sponsored by the National Cancer Institute. This program sends up to 5 messages per day for up to 2 weeks prior to the target quit day and 6 weeks following the target quit day (total duration may be longer if participants elect to change the target quit day). The text messages offer tips to help enrollees achieve their goal of quitting smoking and offer real-time interactive tips when participants text in responses indicating cravings, negative moods, or slips. Participants have the option to reset quit dates and have the option to unsubscribe at any time by texting STOP to the program. |
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| No SmokefreeTXT | Behavioral | Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered. |
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| Financial Incentives for Treatment Engagement | Behavioral | Incentives for treatment engagement are for each counseling session and for staying enrolled in SmokefreeTXT for six weeks. These incentives are designed to bolster motivation to stay engaged in treatment and to offset the costs and effort of treatment engagement (in terms of cell phone minutes). |
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| No Financial Incentives for Treatment Engagement | Behavioral | No Financial Incentives for Treatment Engagement are offered. |
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Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG002 | 1-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment |
| FG003 | 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG004 | 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and financial incentives for treatment engagement |
| FG005 | 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG006 | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and financial incentives for treatment engagement |
| FG007 | 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG008 | 4-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement |
| FG009 | 4-Call, Patch, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG010 | 4-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment engagement |
| FG011 | 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG012 | 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and financial incentives for treatment engagement |
| FG013 | 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and no financial incentives for treatment engagement |
| FG014 | 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and financial incentives for treatment engagement |
| FG015 | 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and no financial incentives for treatment engagement |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement |
| BG001 | 1-Call, Patch, SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG002 | 1-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment |
| BG003 | 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG004 | 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and financial incentives for treatment engagement |
| BG005 | 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG006 | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and financial incentives for treatment engagement |
| BG007 | 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG008 | 4-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement |
| BG009 | 4-Call, Patch, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG010 | 4-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment engagement |
| BG011 | 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG012 | 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and financial incentives for treatment engagement |
| BG013 | 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG014 | 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and financial incentives for treatment engagement |
| BG015 | 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and no financial incentives for treatment engagement |
| BG016 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Gender was missing for 2 randomized participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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 | 7-Day Point-Prevalence Abstinence | Participants will be coded as abstinent if they self-report no smoking for the past 7 days at the assessment endpoint (6 month follow-up) and provide a saliva sample for cotinine testing with a value of <4 ng/ml. Participants will be considered not abstinent if they are lost to follow-up, report any smoking in the past 7 days, return a saliva sample with cotinine greater than or equal to 4 ng/ml, or fail to return a usable saliva sample. | All randomized participants were included in intent-to-treat analyses. | Posted | Count of Participants | Participants | 6-months |
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6 months from target quit date (could be 7 months from study enrollment)
The study team assessed hospitalizations at 26-week follow-up as serious adverse assessments. Non-serious adverse events care were assessed by quitline coaches during quitline care and addressed according to standing quitline protocols.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement | 0 | 83 | 7 | 83 | 0 | 83 |
| EG001 | 1-Call, Patch, SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement | 0 | 84 | 5 | 84 | 0 | 84 |
| EG002 | 1-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment | 2 | 80 | 11 | 80 | 0 | 80 |
| EG003 | 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement | 0 | 85 | 12 | 85 | 0 | 85 |
| EG004 | 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and financial incentives for treatment engagement | 0 | 82 | 11 | 82 | 0 | 82 |
| EG005 | 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and no financial incentives for treatment engagement | 1 | 82 | 4 | 82 | 0 | 82 |
| EG006 | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and financial incentives for treatment engagement | 0 | 84 | 10 | 84 | 0 | 84 |
| EG007 | 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and no financial incentives for treatment engagement | 1 | 82 | 5 | 82 | 0 | 82 |
| EG008 | 4-Call, Patch, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement | 1 | 80 | 6 | 80 | 0 | 80 |
| EG009 | 4-Call, Patch, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement | 1 | 81 | 12 | 81 | 0 | 81 |
| EG010 | 4-Call, Patch, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment engagement | 0 | 81 | 12 | 81 | 0 | 81 |
| EG011 | 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement | 0 | 80 | 10 | 80 | 0 | 80 |
| EG012 | 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and financial incentives for treatment engagement | 1 | 82 | 5 | 82 | 0 | 82 |
| EG013 | 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and no financial incentives for treatment engagement | 1 | 85 | 10 | 85 | 0 | 85 |
| EG014 | 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and financial incentives for treatment engagement | 0 | 82 | 7 | 82 | 0 | 82 |
| EG015 | 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and no financial incentives for treatment engagement | 1 | 83 | 12 | 83 | 0 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection prompting hospitalization | Infections and infestations | Systematic Assessment |
| ||
| Cardiovascular diagnoses and events | Cardiac disorders | Systematic Assessment |
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| Anemia or bleeding disorder | Blood and lymphatic system disorders | Systematic Assessment |
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| Diabetes complications, thyroid disorder | Endocrine disorders | Systematic Assessment |
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| Double vision | Eye disorders | Systematic Assessment |
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| Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia) | Gastrointestinal disorders | Systematic Assessment |
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| Injury or poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cancer, biopsy, polyp, or cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse | Nervous system disorders | Systematic Assessment |
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| Pregnancy, delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Reaction to new psychiatric medication | Product Issues | Systematic Assessment |
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| Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms | Psychiatric disorders | Systematic Assessment |
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| Kidney disease, or kidney or bladder infection | Renal and urinary disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease or need for supplemental oxygen | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Planned orthopedic, gastric, or hernia surgery | Surgical and medical procedures | Systematic Assessment |
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| Unknown or other reason for hospitalization | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle McCarthy | University of Wisconsin School of Medicine and Public Health | 6082655949 | demccarthy@ctri.wisc.edu |
| Jun 14, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2020 | Sep 19, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
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