Status:
ACTIVE_NOT_RECRUITING
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking-Related Carcinoma
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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-Cigaret...
Detailed Description
PRIMARY OBJECTIVES: I. To characterize the effects of switching to nicotine versus (vs.) placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product accep...
Eligibility Criteria
Inclusion
- 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
- 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 hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
- Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
- Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2026
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT03856515
Start Date
June 2 2022
End Date
August 31 2026
Last Update
November 4 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030