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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: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT04525755 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 652 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (987% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group
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 |
What the finished NCT04525755 record still lists
NCT04525755 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (987% higher).
The record links to 0 conditions, and to 2 interventions - of which Nicotine Replacement Therapy (NRT) is the first listed.
NCT04525755 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04525755's enrollment target sits among peer trials
652 22nd of 2000 higher than 1,979 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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