Tobacco Use CessationPhase 4IQSNCT03538938
Improving Quitline Support Study
A Phase 4 study testing 1-Call Quitline Counseling, 4-Call Quitline Counseling and Nicotine patch in people with Tobacco Use Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- 1-Call Quitline Counseling, 4-Call Quitline Counseling and Nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,316 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Uninsured, covered by BadgerCareWisconsin or another Medicaid program, or has no more than a high school education
- Lives in Wisconsin
- Age 18 or older
- English speaking
- 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)
- Must have completed standard WTQL treatment including at least one counseling call 2.5-18 months prior to study recruitment
- 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
- Willing to set a new quit day within 2 weeks
Who cannot join
- 1. Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
Seattle, Washington, 98104
About this study
Official title: Improving Quitline Support Study: Optimizing Remotely Delivered Smoking Cessation Services for Low-Income Smokers
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.
Read the detailed description
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.
- Conditions
- Tobacco Use Cessation
- Being tested
- 1-Call Quitline Counseling, 4-Call Quitline Counseling, Nicotine patch, Nicotine Patch and Nicotine Lozenge, SmokefreeTXT
- Keywords
- Smoking, Smoking cessation, Quitline, Nicotine Replacement Therapy, SmokefreeTXT text messages, Financial incentives
- Medical subject headings
- Tobacco Use Cessation, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Call Quitline CounselingBehavioural
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 CounselingBehavioural
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 patchDrug
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 LozengeDrug
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).
SmokefreeTXTBehavioural
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 SmokefreeTXTBehavioural
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
Financial Incentives for Treatment EngagementBehavioural
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 EngagementBehavioural
No Financial Incentives for Treatment Engagement are offered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: No SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: No SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: No SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 1-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: No SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: No SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine patch; Behavioral: No SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: No SmokefreeTXT; Behavioral: Financial Incentives for Treatment Engagement |
| 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. Receives: Behavioral: 4-Call Quitline Counseling; Drug: Nicotine Patch and Nicotine Lozenge; Behavioral: No SmokefreeTXT; Behavioral: No Financial Incentives for Treatment Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start7 Jun 2018
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Four-factor fully-crossed factorial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, Consumer Wellness Solutions, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Danielle E. McCarthy, PhD, Principal investigator, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538938
- Sponsor's protocol ID
- 2017-0553
- Other IDs
- Protocol Version 11/18/2020, 1R01CA218156-01, A534252, SMPH\MEDICINE\TOBACCO RE, UW20069
- Acronym
- IQS
- Status last verified
- Jul 2024
- First submitted
- 3 May 2018
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: * Behavioral, health, and economic data and outcomes for all participants in the primary research. * Data on individual differences and risk factors for treatment acceptance, smoking cessation outcomes, and response to cessation treatments. 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.
Publications
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.
PubMed 39504025
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quitline Support Study: Optimizing Remotely Delivered Smoking Cessation Services for Low-Income Smokers
- ClinicalTrials.gov ID
- NCT03538938
- Acronym / sponsor ID
- IQS / 2017-0553
- Conditions
- Tobacco Use Cessation
- Keywords
- Smoking, Smoking cessation, Quitline, Nicotine Replacement Therapy, SmokefreeTXT text messages, Financial incentives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- George Washington University, Consumer Wellness Solutions, National Cancer Institute (NCI)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- Model description
- Four-factor fully-crossed factorial design
| Arm | Type | Receives |
|---|---|---|
| 1-Call, Patch, SmokefreeTXT, Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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, Patch, SmokefreeTXT, No Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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, Patch, No SmokefreeTXT, Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: No SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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, Patch, No SmokefreeTXT, No Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: No SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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, Patch+Loz, SmokefreeTXT, Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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, Patch+Loz, SmokefreeTXT, No Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: No SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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, Patch+Loz, No SmokefreeTXT, No Financial Incentive | Experimental | Behavioral: 1-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: No SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: No SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine patch, Behavioral: No SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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, Patch+Loz, SmokefreeTXT, No Financial Incentive | Experimental | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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, Patch+Loz, No SmokefreeTXT, Financial Incentive | Experimental | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: No SmokefreeTXT, Behavioral: Financial Incentives for Treatment EngagementParticipants 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 | Behavioral: 4-Call Quitline Counseling, Drug: Nicotine Patch and Nicotine Lozenge, Behavioral: No SmokefreeTXT, Behavioral: No Financial Incentives for Treatment EngagementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Uninsured, covered by BadgerCareWisconsin or another Medicaid program, or has no more than a high school education
- Lives in Wisconsin
- Age 18 or older
- English speaking
- 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)
Key exclusion criteria (1 listed)
- 1. Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Call Quitline CounselingThe 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. | Behavioural | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 1-Call, Patch, No SmokefreeTXT, Financial Incentive, 1-Call, Patch, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch, SmokefreeTXT, Financial Incentive, 1-Call, Patch, SmokefreeTXT, No Financial Incentive |
| 4-Call Quitline CounselingThe 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. | Behavioural | 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 4-Call, Patch, No SmokefreeTXT, Financial Incentive, 4-Call, Patch, No SmokefreeTXT, No Financial Incentive, 4-Call, Patch, SmokefreeTXT, Financial Incentive, 4-Call, Patch, SmokefreeTXT, No Financial Incentive |
| Nicotine patchNicotine 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). | Drug | 1-Call, Patch, No SmokefreeTXT, Financial Incentive, 1-Call, Patch, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch, SmokefreeTXT, Financial Incentive, 1-Call, Patch, SmokefreeTXT, No Financial Incentive, 4-Call, Patch, No SmokefreeTXT, Financial Incentive, 4-Call, Patch, No SmokefreeTXT, No Financial Incentive, 4-Call, Patch, SmokefreeTXT, Financial Incentive, 4-Call, Patch, SmokefreeTXT, No Financial Incentive |
| Nicotine Patch and Nicotine LozengeThe 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). | Drug | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive |
| SmokefreeTXTSmokefreeTXT 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. | Behavioural | 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 1-Call, Patch, SmokefreeTXT, Financial Incentive, 1-Call, Patch, SmokefreeTXT, No Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 4-Call, Patch, SmokefreeTXT, Financial Incentive, 4-Call, Patch, SmokefreeTXT, No Financial Incentive |
| No SmokefreeTXTProactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered. | Behavioural | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch, No SmokefreeTXT, Financial Incentive, 1-Call, Patch, No SmokefreeTXT, No Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive, 4-Call, Patch, No SmokefreeTXT, Financial Incentive, 4-Call, Patch, No SmokefreeTXT, No Financial Incentive |
| Financial Incentives for Treatment EngagementIncentives 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). | Behavioural | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 1-Call, Patch, No SmokefreeTXT, Financial Incentive, 1-Call, Patch, SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive, 4-Call, Patch, No SmokefreeTXT, Financial Incentive, 4-Call, Patch, SmokefreeTXT, Financial Incentive |
| No Financial Incentives for Treatment EngagementNo Financial Incentives for Treatment Engagement are offered. | Behavioural | 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 1-Call, Patch, No SmokefreeTXT, No Financial Incentive, 1-Call, Patch, SmokefreeTXT, No Financial Incentive, 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive, 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive, 4-Call, Patch, No SmokefreeTXT, No Financial Incentive, 4-Call, Patch, SmokefreeTXT, No Financial Incentive |
Primary outcome
7-Day Point-Prevalence Abstinence
Time frame: 6-months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39504025Kaye 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.
- Individual participant dataSharing planned: Yes. 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: * Behavioral, health, and economic data and outcomes for all participants in the primary research. * Data on individual differences and risk factors for treatment acceptance, smoking cessation outcomes, and response to cessation treatments. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle E. McCarthy, PhD principal investigator
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1-Call Quitline Counseling, 4-Call Quitline Counseling and Nicotine patch in people with Tobacco Use Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point-Prevalence Abstinence (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.