Your session is about to expire
← Back to Search
Nicotine Replacement Therapy
Financial Incentives for Treatment Engagement for Quitting Smoking (IQS Trial)
Phase 4
Waitlist Available
Led By Danielle E. McCarthy, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
IQS Trial Summary
This trial is testing different ways to help low-education, uninsured or Medicaid-eligible smokers who didn't quit smoking the first time they tried. 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). The strategies include: increasing the intensity of nicotine replacement medication, 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.
IQS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-Day Point-Prevalence Abstinence
IQS Trial Design
16Treatment groups
Experimental Treatment
Group I: 4-Call, Patch, SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group II: 4-Call, Patch, SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group III: 4-Call, Patch, No SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group IV: 4-Call, Patch, No SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group V: 4-Call, Patch+Loz, SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group VI: 4-Call, Patch+Loz, SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group VII: 4-Call, Patch+Loz, No SmokefreeTXT,No Financial IncentiveExperimental Treatment4 Interventions
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.
Group VIII: 4-Call, Patch+Loz, No SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group IX: 1-Call, Patch, SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group X: 1-Call, Patch, SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group XI: 1-Call, Patch, No SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group XII: 1-Call, Patch, No SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group XIII: 1-Call, Patch+Loz, SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group XIV: 1-Call, Patch+Loz, SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Group XV: 1-Call, Patch+Loz, No SmokefreeTXT, No Financial IncentiveExperimental Treatment4 Interventions
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.
Group XVI: 1-Call, Patch+Loz, No SmokefreeTXT, Financial IncentiveExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
SmokefreeTXT
2018
Completed Phase 4
~1390
Financial Incentives for Treatment Engagement
2018
Completed Phase 4
~1320
Nicotine
FDA approved
No SmokefreeTXT
2018
Completed Phase 4
~1320
4-Call Quitline Counseling
2018
Completed Phase 4
~1320
1-Call Quitline Counseling
2018
Completed Phase 4
~1320
No Financial Incentives for Treatment Engagement
2018
Completed Phase 4
~1320
Find a Location
Who is running the clinical trial?
George Washington UniversityOTHER
243 Previous Clinical Trials
452,458 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,166,071 Total Patients Enrolled
2 Trials studying Quitting Smoking
13,098 Patients Enrolled for Quitting Smoking
Consumer Wellness SolutionsIndustry Sponsor
14 Previous Clinical Trials
14,105 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for this clinical research now?
"Unfortunately, this trial has reached its recruitment quota and is no longer recruiting participants at this time. It was originally posted on June 7th 2018 and last updated on October 3rd 2022. If you would still like to pursue participation in a medical study, there are 23 studies focusing on tobacco addiction currently looking for patients as well as 71 trials seeking individuals who use nicotine patches or lozenges."
Answered by AI
Has the FDA given their stamp of approval to Nicotine Patches and Lozenges?
"Our team has assessed the safety of Nicotine Patch and Nicotine Lozenge to be a 3 due to this being an approved phase 4 trial."
Answered by AI
How many participants are benefiting from this research?
"As of October 3rd 2022, this trial is not presently enrolling participants. This clinical study was first posted on June 7th 2018 and has since been inactive. Nonetheless, there are 23 tobacco studies and 71 Nicotine Patch/Lozenge trials actively accepting volunteers at the moment."
Answered by AI
Could you please outline the research results of past experiments that incorporated Nicotine Patch and Nicotine Lozenge?
"Presently, Nicotine Patch and Nicotine Lozenge research is being conducted through 71 clinical trials with 5 of them in the last stage. The majority are hosted out of Green Bay, WI yet there are 204 other sites that have opened up spaces for enrolment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger