STARS (Smoking Treatment And Remote Sampling) Study

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Nicotine; Varenicline

Criteria

Eligibility criteria include:

1. age 18+;

2. daily smoker (25+ days per previous month);

3. smoking 5+ cigarettes/day;

4. smoking > 1yr;

5. some interest in eventual quitting (>2 on 10-point scale);

6. has a primary care doctor and has seen that doctor at least once in past year;

7. not currently pregnant, breastfeeding, or planning to become pregnant;

8. no suicidal ideation in past month, nor any lifetime suicide attempt;

9. no reports of hallucinations;

10. no reports of history of seizures; nor cardiac/renal disease

11. own a smartphone or have regular (daily) access/use of email

12. if female, willing to take a pregnancy test

13. not currently taking any medications to help quit smoking

14. no diagnosis of schizophrenia or bipolar disorder

15. no members of the same household currently enrolled in the study