NCT04525755

STARS (Smoking Treatment And Remote Sampling) Study

A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Smoking Cessation
• Tobacco Smoking
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Varenicline 0.5 MG	varenicline comes in bottles of 56 - 0.5 mg pills
DRUG	Nicotine Replacement Therapy (NRT)	28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)

Timeline

• Start date: 2021-02-08
• Primary completion: 2025-04-05
• Completion: 2025-04-05
• First posted: 2020-08-25
• Last updated: 2026-02-17
• Results posted: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study