Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes (NCT03856515) | Clinical Trial Compass
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 range21 Years
SexALL
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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…