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NCT04525755 · ClinicalTrials.gov registry record · Phase 1
STARS (Smoking Treatment And Remote Sampling) Study
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 652
- Enrollment target
NCT04525755 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 652 participants.
The verdict
NCT04525755, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 652 participants
- Enrollment target
Study Summary
This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample. Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study. The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.
Interventions
- DRUG Nicotine Replacement Therapy (NRT)
- DRUG Varenicline 0.5 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2025-04-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04525755
The ClinicalTrials.gov registry entry for NCT04525755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 652 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nicotine Replacement Therapy (NRT) is the first listed.
NCT04525755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04525755 about?
NCT04525755 is a clinical study titled "STARS (Smoking Treatment And Remote Sampling) Study". This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample. Participants will either receive a sample of varenicline, nicotine patches and loz...
What is the current status of trial NCT04525755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 652 participants. The study started on 2021-02-08. Estimated completion is 2025-04-05.
What interventions are being tested in trial NCT04525755?
The interventions under investigation include: Nicotine Replacement Therapy (NRT) (DRUG), Varenicline 0.5 MG (DRUG).
Who is sponsoring clinical trial NCT04525755?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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