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Low-Nicotine smokes put to the heart test

NCT ID NCT05707871

Knowledge-focused Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early-phase study is testing whether cigarettes with very low nicotine content cause less strain on the heart compared to regular cigarettes. Researchers will measure heart rate and heart rate variability in 49 daily and non-daily smokers after smoking different types of research cigarettes. The goal is to gather basic evidence on cardiovascular effects, which could guide future tobacco policies.

What this could mean

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

Active substance
very low nicotine content cigarettes
What this could lead to
If successful, this could help understand whether reducing nicotine in cigarettes lowers cardiovascular harm, potentially informing future tobacco regulation.
What could go wrong
This is a very early, small study (49 participants) measuring short-term heart rate changes, not long-term health outcomes. Results may not apply to real-world smoking patterns.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 49 people

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

Started

Apr 2023

Expected to finish

Dec 2026

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Self-reported cigarette smoking at least once in the past 30 days * ≥21 years old * Willingness to smoke research cigarettes or usual brand cigarettes during lab visit. * Ability to speak, comprehend, and read English sufficiently to complete study procedures Exclusion Criteria: * Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism \& blood clots in legs and arm in the past 3 months * Body temperature ≥ 100.4˙F * Unstable health conditions interfering with electrocardiogram (ECG) measurements * Self-reported diagnosis of hyperthyroidism or thyrotoxicosis * Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding. * Currently seeking treatment to quit smoking

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Cigarette Smoking nicotine dependence Tobacco Use

As listed by the trial registrant

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

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

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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