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Free samples of Quit-Smoking drugs mailed to your door: does it work?

NCT ID NCT04525755

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether mailing free samples of varenicline (Chantix) or nicotine patches and lozenges helps smokers quit. 652 daily smokers were randomly assigned to receive a one-time sample of varenicline, nicotine replacement products, or no medication. Participants were not required to quit or use the samples. The study lasted 6 months and tracked smoking habits through surveys and daily diaries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
varenicline (Chantix) and nicotine replacement therapy (patches and lozenges)
What this could lead to
If successful, this approach could make it easier for smokers to try quitting by offering free medication samples remotely, potentially increasing quit rates.
What could go wrong
This is an early-phase study with a relatively small sample. The results may not apply to all smokers, and participants were not required to quit, so the true effect on quitting is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

652 people

The number who actually took part.

Started

Feb 2021

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cigarette Smoking Smoking Smoking Cessation Tobacco Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cigarette smoking Smoking Smoking cessation Tobacco smoking

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.