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NCT03521141 · ClinicalTrials.gov registry record · Phase 2
PRecision Interventions for SMoking in the SCCS
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03521141 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 67 participants.
The verdict
NCT03521141, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.
Interventions
- DRUG Varenicline
- DRUG Nicotine patch
- GENETIC Nicotine metabolism
- GENETIC Genetically-informed lung cancer risk score
- BEHAVIORAL NCI "Clearing the Air"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03521141
The ClinicalTrials.gov registry entry for NCT03521141 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.
NCT03521141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03521141 about?
NCT03521141 is a clinical study titled "PRecision Interventions for SMoking in the SCCS". Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with med...
What is the current status of trial NCT03521141?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2018-05-18. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT03521141?
The interventions under investigation include: Varenicline (DRUG), Nicotine patch (DRUG), Nicotine metabolism (GENETIC), Genetically-informed lung cancer risk score (GENETIC), NCI "Clearing the Air" (BEHAVIORAL).
Who is sponsoring clinical trial NCT03521141?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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