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SmokingPhase 1/2NCT04525755

STARS (Smoking Treatment And Remote Sampling) Study

A Phase 1/2 study testing Varenicline 0.5 MG and Nicotine Replacement Therapy (NRT) in people with Smoking and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking, Smoking Cessation, Tobacco Smoking
What is being tested?
Varenicline 0.5 MG and Nicotine Replacement Therapy (NRT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
652 participants
Where
1 siteUnited States
Study dates
8 Feb 2021to 5 Apr 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Being tested
Varenicline 0.5 MG, Nicotine Replacement Therapy (NRT)
Medical subject headings
Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Varenicline 0.5 MGDrug

    Also called Chantix, Varenicline Pill

    varenicline comes in bottles of 56 - 0.5 mg pills

  • Nicotine Replacement Therapy (NRT)Drug

    Also called NRT Sampling, Nicotine Patches and Lozenges, Nicotine Replacement Therapy Sampling, NRT

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

Study groups in NCT04525755
Study groupRoleWhat they receive
Varenicline (.5mg BID)ExperimentalParticipants 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.
Receives: Drug: Varenicline 0.5 MG
Nicotine Replacement Therapy (NRT)Active comparatorParticipants 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.
Receives: Drug: Nicotine Replacement Therapy (NRT)
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At six-month follow up

Secondary outcomes (3)

  1. 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

    Measured: At the week 4 and week 26 follow up follow up

  2. 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

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

  3. 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

    Measured: At 4 and 24 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2020
  2. Study start8 Feb 2021
  3. Primary completion5 Apr 2025
  4. Study completion5 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525755
Sponsor's protocol ID
Pro00098479
Status last verified
Jan 2026
First submitted
19 Aug 2020
Last updated
17 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carpenter MJ, Smith TT, Wahlquist AE, Toll BA, Cropsey KL, Ware EC, Kaczmar JM, Dahne J, Gray KM. Medication Samples and Smoking Cessation Among Adults: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611418. doi: 10.1001/jamanetworkopen.2026.11418.

    PubMed 42101840

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Varenicline 0.5 MG and Nicotine Replacement Therapy (NRT) in people with Smoking and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Cessation (time frame: At six-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525755, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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