Trial · NCT04525755
STARS (Smoking Treatment And Remote Sampling) Study
NCT04525755, Phase 1, Phase 2, Completed, Medical University of South Carolina; results first posted 2026-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STARS (Smoking Treatment And Remote Sampling) Study. Trials, record NCT04525755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04525755
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STARS (Smoking Treatment And Remote Sampling) Study
- NCT number
- NCT04525755
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 652 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking
- Interventions
- Varenicline 0.5 MG, Nicotine Replacement Therapy (NRT)
- First posted
- 2020-08-25
- Last updated
- 2026-02-17
- Results first posted
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Smoking Cessation | At six-month follow up | 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 |
| Secondary | Reduction in Smoking | At the week 4 and week 26 follow up follow up | Percentage of participants who have reduced their smoking by at least 50%, at both Week 4 and Week 26 follow-up, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group |
| Secondary | Any Quit Attempts | From study enrollment through end of six-month follow up (cumulative percent over six months) | Any self-defined attempt and any 24-hr quit attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group |
| Secondary | Use of Smoking Cessation Medication | At 4 and 24 week follow-up | Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Smoking Cessation | At six-month follow up | Percent | NUMBER | |
| SECONDARY | Reduction in Smoking | At the week 4 and week 26 follow up follow up | percent | NUMBER | |
| SECONDARY | Any Quit Attempts | From study enrollment through end of six-month follow up (cumulative percent over six months) | percent | NUMBER | |
| SECONDARY | Use of Smoking Cessation Medication | At 4 and 24 week follow-up | percent | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Smoking Cessation | Varenicline (.5mg BID) | 16.7 | Percent | ||
| Smoking Cessation | Nicotine Replacement Therapy (NRT) | 8.1 | Percent | ||
| Smoking Cessation | Control Group | 9.9 | Percent | ||
| Reduction in Smoking | Varenicline (.5mg BID) | 4 week follow-up | 28.9 | percent | |
| Reduction in Smoking | Nicotine Replacement Therapy (NRT) | 4 week follow-up | 27.3 | percent | |
| Reduction in Smoking | Control Group | 4 week follow-up | 11.2 | percent | |
| Reduction in Smoking | Varenicline (.5mg BID) | 26 week follow-up | 33.3 | percent | |
| Reduction in Smoking | Nicotine Replacement Therapy (NRT) | 26 week follow-up | 25 | percent | |
| Reduction in Smoking | Control Group | 26 week follow-up | 19.25 | percent | |
| Any Quit Attempts | Varenicline (.5mg BID) | Any self-defined quit attempt over six month follow-up | 68 | percent |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline (.5mg BID) | 318 | |
| Overall Study | STARTED | Nicotine Replacement Therapy (NRT) | 172 | |
| Overall Study | STARTED | Control Group | 162 | |
| Overall Study | COMPLETED | Varenicline (.5mg BID) | 318 | |
| Overall Study | COMPLETED | Nicotine Replacement Therapy (NRT) | 172 | |
| Overall Study | COMPLETED | Control Group | 161 | |
| Overall Study | NOT COMPLETED | Varenicline (.5mg BID) | 0 | |
| Overall Study | NOT COMPLETED | Nicotine Replacement Therapy (NRT) | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Any Related Adverse Event | Investigations | Varenicline (.5mg BID) | 191 | 318 | |
| other | Any Related Adverse Event | Investigations | Nicotine Replacement Therapy (NRT) | 7 | 172 | |
| other | Any Related Adverse Event | Investigations | Control Group | 69 | 161 | |
| other | Any NON-Related and Non-Serious Adverse Events | General disorders | Varenicline (.5mg BID) | 31 | 318 | |
| other | Any NON-Related and Non-Serious Adverse Events | General disorders | Nicotine Replacement Therapy (NRT) | 88 | 172 | |
| other | Any NON-Related and Non-Serious Adverse Events | General disorders | Control Group | 68 | 161 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline (.5mg BID) | 0 | 318 |
| Total, all-cause mortality | Nicotine Replacement Therapy (NRT) | 0 | 172 |
| Total, all-cause mortality | Control Group | 0 | 161 |
| Total, other adverse events | Varenicline (.5mg BID) | 222 | 318 |
| Total, other adverse events | Nicotine Replacement Therapy (NRT) | 95 | 172 |
| Total, other adverse events | Control Group | 69 | 161 |
| Total, serious adverse events | Varenicline (.5mg BID) | 0 | 318 |
| Total, serious adverse events | Nicotine Replacement Therapy (NRT) | 0 | 172 |
| Total, serious adverse events | Control Group | 0 | 161 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42101840 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04525755
GET https://conductscience.org/api/trials/v1/NCT04525755/results?page=2