Phase 4
N=1,316
Improving Quitline Support Study
Tobacco Use Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03538938 ↗Enrolled (actual)
1,316
Serious AEs
10.6%
Results posted
Jul 2024
Primary outcome: Primary: 7-Day Point-Prevalence Abstinence — 11; 7; 8; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 1-Call Quitline Counseling (Behavioral); 4-Call Quitline Counseling (Behavioral); Nicotine patch (Drug); Nicotine Patch and Nicotine Lozenge (Drug); SmokefreeTXT (Behavioral); No SmokefreeTXT (Behavioral); Financial Incentives for Treatment Engagement (Behavioral); No Financial Incentives for Treatment Engagement (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-Day Point-Prevalence Abstinence |
11; 7; 8; 10; 6; 10 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment
Data sourced from ClinicalTrials.gov (NCT03538938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.