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Completed

NCT Number: NCT03856515

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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 acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers.

II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms.

EXPLORATORY OBJECTIVE:

I. To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers.

OUTLINE:

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Nicotine Replacement

Drug

Received NRT (Electronic Cigarette - With Nicotine)

Other names: Nicotine Replacement Therapy, NRT

Questionnaire Administration

Other

Ancillary studies

Electronic cigarette

Device

Electronic Cigarette - with Nicotine

Primary outcomes

  1. Cigarettes Per Day

    Time frame: 2 weeks

    Mean cigarettes per day (CPD) smoked during the phase

Secondary outcomes

  1. Electronic Cigarette Sessions Per Day

    Time frame: 2 weeks

    Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants.

  2. Total Nicotine Equivalents (TNE)

    Time frame: 2 weeks

    A measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants.

  3. Anabasine

    Time frame: 2 weeks

    A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.

  4. Nicotelline

    Time frame: 2 weeks

    A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.

  5. Perceived Health Risk Questionnaire (PHRQ)

    Time frame: 2 weeks

    Evaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes.

  6. Product Evaluation Scales (PES)

    Time frame: 2 weeks

    Evaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings.

  7. Implicit Association Test (IAT)

    Time frame: 2 weeks

    Evaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product

  8. Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)

    Time frame: 2 weeks

    Evaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use

  9. Purchase Task Breakpoint Measure

    Time frame: 2 weeks

    Evaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price.

  10. Purchase Task Demand Intensity Measure

    Time frame: 2 weeks

    Evaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0

  11. Purchase Task Omax Measure

    Time frame: 2 weeks

    Evaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure

  12. Purchase Task Pmax Measure

    Time frame: 2 weeks

    Evaluation of the Purchase Task Pmax measure (price at which expenditure is maximized) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.01 - 1001, the price of the cigarette or electronic cigarette puffs when the Omax is reached

  13. Purchase Task Elasticity of Demand Measure

    Time frame: 2 weeks

    Evaluation of the Purchase Task Elasticity of Demand measure (sensitivity of product consumption to increases in cost) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.0001 - 2.69, the elasticity of the demand for cigarettes or electronic cigarette puffs, with higher values indicating a greater sensitivity in reducing the consumption in response to the price increases

  14. Fagerström Test for Cigarette Dependence (FTCD)

    Time frame: 2 weeks

    Evaluation of cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 10, with higher values indicating greater cigarette dependence

  15. Penn State Electronic Cigarette Dependence Index (PSECDI)

    Time frame: 2 weeks

    Evaluation of electronic cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 20, with higher scores indicating greater electronic cigarette dependence

  16. Minnesota Nicotine Withdrawal Scale-Revised (MNWS)

    Time frame: 2 weeks

    Evaluation of nicotine withdrawal symptoms collected at the end of each phase for male and female participants. Range 0 to 60, with higher scores indicating greater nicotine withdrawal

  17. Questionnaire of Smoking Urges-Brief (QSU-Brief)

    Time frame: 2 weeks

    Evaluation of the craving to smoke cigarettes collected at the end of each phase for male and female participants. Range 1 to 10, with higher values indicating greater urge to smoke

  18. Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos)

    Time frame: 2 weeks

    Evaluation of positive affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater positive affect

  19. Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg)

    Time frame: 2 weeks

    Evaluation of negative affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater negative affect

  20. Smartphone Daily Measures of Nicotine Dependence Symptoms

    Time frame: 2 weeks

    Evaluation of mean nicotine dependence symptoms collected daily during each phase. Range 1 to 5, with higher values indicating greater nicotine dependence symptoms

  21. American Thoracic Society Questionnaire (ATSQ)

    Time frame: 2 weeks

    Evaluation of respiratory symptoms collected at the end of each phase for male and female participants. Range 8 to 40, with higher numbers indicating more respiratory symptoms

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 27, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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