Phase 2
Completed N=652
STARS (Smoking Treatment And Remote Sampling) Study
Smoking · Smoking Cessation · Tobacco Smoking · Cigarette Smoking
Source: ClinicalTrials.gov NCT04525755 ↗
Enrolled (actual)
652
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Smoking Cessation — 16.7; 8.1; 9.9 Percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation |
16.7; 8.1; 9.9 | — |
| SECONDARY Reduction in Smoking |
28.9; 27.3; 11.2; 33.3; 25; 19.25 | — |
| SECONDARY Any Quit Attempts |
68; 65; 58; 48; 40; 39 | — |
| SECONDARY Use of Smoking Cessation Medication |
78.7; 74.7; 7.8; 28; 48.8; 16.5 | — |
Eligibility Criteria
Eligibility criteria include:
- age 18+;
- daily smoker (25+ days per previous month);
- smoking 5+ cigarettes/day;
- smoking > 1yr;
- some interest in eventual quitting (>2 on 10-point scale);
- has a primary care doctor and has seen that doctor at least once in past year;
- not currently pregnant, breastfeeding, or planning to become pregnant;
- no suicidal ideation in past month, nor any lifetime suicide attempt;
- no reports of hallucinations;
- no reports of history of seizures; nor cardiac/renal disease
- own a smartphone or have regular (daily) access/use of email
- if female, willing to take a pregnancy test
- not currently taking any medications to help quit smoking
- no diagnosis of schizophrenia or bipolar disorder
- no members of the same household currently enrolled in the study
Data sourced from ClinicalTrials.gov (NCT04525755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.