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Little cigars under the microscope: new study reveals hidden health risks

NCT ID NCT06310187

Knowledge-focused Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how smoking little cigars affects levels of harmful chemicals called oxidants in the body. Researchers will compare three types of smoking: high-oxidant little cigars, low-oxidant little cigars, and regular cigarettes. Fifty daily smokers will provide breath, blood, saliva, and cheek cell samples before and after smoking to measure these effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

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

21 to 65 years

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.

Inclusion Criteria: 1. Aged 21 - 65 years old 2. Daily cigarette smoker (\>= 1 cigarette per day); 3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter 4. No current or past use of Little Cigars 5. All other forms of nicotine must be used \<6 days out of the past 30 days. 6. Able to read and write in English 7. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days 8. No plan to quitting smoking in the next 3 months Exclusion Criteria: 1. Women who are pregnant and/or nursing or trying to become pregnant 2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina) 3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data 4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months 5. Exhaled Carbon Monoxide (CO) measurement of \>= 17 parts per million

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Conditions

The condition(s) this trial relates to.

nicotine dependence Tobacco Use

As listed by the trial registrant

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

Oxidative stress Tobacco use

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Penn State College of Medicine

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

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