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New study tests what happens to your body when you switch from cigarettes to a Lab-Grade E-Cig

NCT ID NCT04003805

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 what chemicals smokers are exposed to when they switch from regular cigarettes to a standardized research e-cigarette (SREC). About 47 adult smokers who smoke at least 5 cigarettes daily will stop smoking and use only the SREC for a period. Researchers will measure nicotine and other harmful substances in their urine and saliva to understand how switching affects exposure to toxins and potential cancer-causing agents.

What this could mean

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

Active substance
Standardized Research E-cigarette (SREC) with nicotine e-liquid
What this could lead to
If successful, this study could provide reliable data on how switching from cigarettes to a standardized e-cigarette changes exposure to harmful chemicals, helping to inform future tobacco harm reduction strategies.
What could go wrong
This is a small, early-phase study (47 participants) focused on measuring biomarkers, not health outcomes. Results may not apply to real-world e-cigarettes, which vary widely. The study does not test whether e-cigarettes are safe or effective for quitting smoking.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

47 people

The number who actually took part.

Started

May 2022

Expected to finish

Aug 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

18 to 65 years

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: * Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine; * Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product; * Biochemically confirmed regular smoking status by a NicAlert test level of 6; * Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group); * No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures); * Subjects are in good physical health (no unstable medical condition); * Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse); * Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes; * Women who are not pregnant or nursing or planning to become pregnant; * Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products). Exclusion Criteria: * Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes; * Currently using nicotine replacement or other tobacco cessation products; * Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data; * Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional); * Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional); * Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional; * Blood alcohol test \> 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once; * Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once; * Pregnant or breastfeeding; * Failure to agree to take adequate protection to avoid becoming pregnant during the study; * Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): * Systolic BP greater than or equal to 160 mm/hg * Diastolic BP greater than or equal to 100 mm/hg * Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) * Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) * Heart rate greater than or equal to 105 bpm * Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) * Expired air carbon monoxide (CO) level greater than 80 ppm; * Self-reported allergies to propylene glycol or vegetable glycerin; * Adverse reactions when previously using electronic cigarettes; * Household member enrolled in the study concurrently; * Unable to read for comprehension or completion of study documents; * Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.

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Conditions

The condition(s) this trial relates to.

Cigarette Smoking

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Minnesota, Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

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