Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1316 participants
INTERVENTIONAL
2018-06-07
2023-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1-Call, Patch, SmokefreeTXT, Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine patch
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
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.
Financial Incentives for Treatment Engagement
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).
1-Call, Patch, SmokefreeTXT, No Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine patch
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
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.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
1-Call, Patch, No SmokefreeTXT, Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine patch
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment Engagement
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).
1-Call, Patch, No SmokefreeTXT, No Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine patch
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
SmokefreeTXT
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.
Financial Incentives for Treatment Engagement
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).
1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive
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 Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
SmokefreeTXT
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.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment Engagement
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).
1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive
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.
1-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
4-Call, Patch, SmokefreeTXT, Financial Incentive
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 Quitline Counseling
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.
Nicotine patch
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
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.
Financial Incentives for Treatment Engagement
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).
4-Call, Patch, SmokefreeTXT, No Financial Incentive
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 Quitline Counseling
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.
Nicotine patch
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
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.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
4-Call, Patch, No SmokefreeTXT, Financial Incentive
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 Quitline Counseling
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.
Nicotine patch
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment Engagement
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).
4-Call, Patch, No SmokefreeTXT, No Financial Incentive
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 Quitline Counseling
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.
Nicotine patch
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive
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.
4-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
SmokefreeTXT
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.
Financial Incentives for Treatment Engagement
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).
4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive
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.
4-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
SmokefreeTXT
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.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive
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 Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment Engagement
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).
4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive
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.
4-Call Quitline Counseling
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.
Nicotine Patch and Nicotine Lozenge
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).
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
Interventions
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1-Call Quitline Counseling
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.
4-Call Quitline Counseling
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.
Nicotine patch
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).
Nicotine Patch and Nicotine Lozenge
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).
SmokefreeTXT
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.
No SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment Engagement
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).
No Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
Eligibility Criteria
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Inclusion Criteria
2. Lives in Wisconsin
3. Age 18 or older
4. English speaking
5. Must provide a unique telephone number not already registered in the Wisconsin Tobacco Quit Line (WTQL) database for this study (to prevent duplicate enrollment and to ensure that only one person per household enrolls)
6. Must have completed standard WTQL treatment including at least one counseling call 2.5-18 months prior to study recruitment
7. Reported smoking at least 6 of the last 7 days at the WTQL follow-up enrollment call (2.5-18 months after completing standard WTQL treatment), with at least 5 cigarettes smoked on 1 or more days
8. Willing to set a new quit day within 2 weeks
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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George Washington University
OTHER
Consumer Wellness Solutions
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Danielle E. McCarthy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Locations
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Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Protocol Version 11/18/2020
Identifier Type: OTHER
Identifier Source: secondary_id
A534252
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\TOBACCO RE
Identifier Type: OTHER
Identifier Source: secondary_id
UW20069
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0553
Identifier Type: -
Identifier Source: org_study_id
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