CompletedNot Applicable

Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes

United States169 participantsStarted 2022-06-02

Plain-language summary

This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 21 years or older * Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days) * Have an address where he/she can receive mail * Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI * Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site. * Willing to use tobacco-flavored study electronic cigarettes * Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit. * The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle. Exclusion Criteria: * Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9 * Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes). * Evidence of cognitive deficits or instability that would preclude reliable study participation. * Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormon…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at whether men and women respond differently when switching from regular cigarettes to e-cigarettes — given my specific smoking history and gender, does my doctor think those findings are relevant to my situation?
2Since the trial measured how many cigarettes per day participants smoked, and it's now completed, has my doctor seen the results, and do they suggest that switching to e-cigarettes actually reduces smoking enough to lower cancer risk for someone like me?
3This study was focused on a smoking-related carcinoma context — before considering e-cigarettes as any kind of harm-reduction strategy, should I first explore proven smoking cessation treatments like nicotine replacement therapy or prescription medications?
4Because this trial has no phase designation, it wasn't testing a drug or procedure in the traditional sense — so how should I interpret its findings compared to, say, a clinical trial testing an actual cancer treatment?
5Given that this trial is completed, is there published data my doctor can point me to, and would the gender-based differences it identified actually change the advice my doctor gives me about quitting smoking?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cigarettes Per Day

Timeframe: 2 weeks

Trial details

NCT IDNCT03856515

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-24

Results submitted2025-03-25

View on ClinicalTrials.gov More Cigarette Smoking-Related Carcinoma trials