STARS (Smoking Treatment And Remote Sampling) Study

NCT04525755 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro00098479
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction in Smoking

  At the week 4 and week 26 follow up follow up

• Any Quit Attempts

  From study enrollment through end of six-month follow up (cumulative percent over six months)

• Use of Smoking Cessation Medication

  At 4 and 24 week follow-up

Study Arms (3)

Varenicline (.5mg BID)

EXPERIMENTAL

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

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

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)

Control Group

NO INTERVENTION

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.

Interventions

Varenicline 0.5 MG DRUG

varenicline comes in bottles of 56 - 0.5 mg pills

Also known as: Chantix, Varenicline Pill

Varenicline (.5mg BID)

Nicotine Replacement Therapy (NRT) DRUG

28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)

Also known as: NRT Sampling, Nicotine Patches and Lozenges, Nicotine Replacement Therapy Sampling, NRT

Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Smoking; Cigarette Smoking

Interventions

Varenicline; Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Principal Investigator
• Organization: Hollings Cancer Center, Medical University of South Carolina

carpente@musc.edu

843.876.2436

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. 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. 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 25, 2020
• Study Start: February 8, 2021
• Primary Completion: April 5, 2025
• Study Completion: April 5, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)