STARS (Smoking Treatment And Remote Sampling) Study

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Tobacco Smoking; Cigarette Smoking
• Intervention / Treatment: Drug: Varenicline 0.5 MG; Drug: Nicotine Replacement Therapy (NRT)

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline (.5mg BID); Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience.	Drug: Varenicline 0.5 MG; varenicline comes in bottles of 56 - 0.5 mg pills; Other Names: Chantix; Varenicline Pill
Active Comparator: Nicotine Replacement Therapy (NRT); Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.	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); Other Names: NRT; NRT Sampling; Nicotine Patches and Lozenges; Nicotine Replacement Therapy Sampling
No Intervention: Control Group; Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	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	At six-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Smoking	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	At the week 4 and week 26 follow up follow up
Any Quit Attempts	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	From study enrollment through end of six-month follow up (cumulative percent over six months)
Use of Smoking Cessation Medication	Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group	At 4 and 24 week follow-up

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): April 5, 2025
• Study Completion (Actual): April 5, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Tobacco Use; Smoking; Smoking Cessation; Cigarette Smoking; Tobacco Smoking; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Therapy; Benzazepines; Quinoxalines; Varenicline; Tobacco Use Cessation Devices; Nicotine Replacement Therapy
• Other Study ID Numbers: Pro00098479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No