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NCT03538938 · ClinicalTrials.gov registry record · Phase 4
Improving Quitline Support Study
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,316
- Enrollment target
NCT03538938: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT03538938 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1,316 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (154% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03538938, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,316 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Nicotine patch
- BEHAVIORAL SmokefreeTXT
- BEHAVIORAL 1-Call Quitline Counseling
- BEHAVIORAL 4-Call Quitline Counseling
- DRUG Nicotine Patch and Nicotine Lozenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,316 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 4 |
What the finished NCT03538938 record still lists
NCT03538938 is an interventional study that assigns participants to a tested intervention. Its 1,316 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (154% higher).
The record links to 0 conditions, and to 5 interventions - of which Nicotine patch is the first listed.
NCT03538938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03538938 about?
NCT03538938 is a clinical study titled "Improving Quitline Support Study". 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 follo...
What is the current status of trial NCT03538938?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,316 participants. The study started on 2018-06-07. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT03538938?
The interventions under investigation include: Nicotine patch (DRUG), SmokefreeTXT (BEHAVIORAL), 1-Call Quitline Counseling (BEHAVIORAL), 4-Call Quitline Counseling (BEHAVIORAL), Nicotine Patch and Nicotine Lozenge (DRUG).
Who is sponsoring clinical trial NCT03538938?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03538938's enrollment target sits among peer trials
1,316 60th of 2000 higher than 1,941 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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