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Could cutting nicotine in cigarettes help smokers switch to E-Cigs?

NCT ID NCT02964182

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 from M.D. Anderson Cancer Center tested what happens when daily and occasional smokers use very low nicotine cigarettes along with e-cigarettes that have different nicotine levels. Researchers measured how many cigarettes people smoked, their nicotine levels, and withdrawal symptoms. The goal was to understand how these products might affect smoking behavior, which could inform future tobacco regulations.

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 and electronic cigarettes with varying nicotine levels
What this could lead to
If successful, this research could help shape policies that reduce smoking by lowering nicotine in cigarettes while offering e-cigarettes as alternatives.
What could go wrong
This is an observational study, not a treatment trial. Results may not apply to all smokers, and the long-term health effects of e-cigarettes are still 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

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

213 people

The number who actually took part.

Started

Oct 2017

Finished

Mar 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

21 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: * Sign consent and agree to all study procedures * Have an address where he/she can receive mail * Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.) * Able to follow verbal and written instructions in English * Willing and able to complete two spirometry sessions (this criterion waived during COVID-19 pandemic) * Be the only participant in their household * Interested in trying novel nicotine products * Daily smokers: \>= 1 cigarette/little cigar per day * Intermittent smokers: \>= 1 cigarette/little cigar per day 4 to 27 days per month * Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit * The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle Exclusion Criteria: * Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes * Current/recent use of certain medications: * Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy \[NRT\], Chantix) * Certain medications to treat depression (last 14 days; e.g., amitriptyline) * A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin) * Self-reported daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week or less or if more frequent, use less than a month's duration * Unstable medical condition as determined by the medical team * Self-reported bronchial or respiratory infection in the last 14 days (this criterion waived during COVID-19 pandemic) * Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is \< 50 (severe to very severe obstruction) (this criterion waived during COVID-19 pandemic) * Self-reported abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months * Meet criteria for major depressive syndrome or suicidality on the Patient Health Questionnaire-9 (PHQ-9) * Self report of past or current diagnosis of bi-polar disorder or schizophrenia/schizoaffective disorder * Self-reported other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos, smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the last month * Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities * Positive urine pregnancy test at screening. Women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test * Women that are breastfeeding or of childbearing potential and not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: * Approved hormonal contraceptives (such as birth control pills, patches, implants or injections) * Barrier methods (such as condom or diaphragm) used with a spermicide, or * An intrauterine device (IUD) * Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use * Subject considered by the investigator to be unsuitable to participate in the study (e.g., due to cognitive deficits or instability to last the entire duration of the study)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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