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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: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT03521141 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Feasibility of delivering precision care (PC) interventions in the Southern Community Cohort Study (SCCS), as evidenced by ability to recruit, engage, and retain participants through end of the study.
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 |
What the finished NCT03521141 record still lists
NCT03521141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.
NCT03521141 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03521141's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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