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

M.D. Anderson Cancer Center169 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

169

Conditions

Cigarette Smoking-Related Carcinoma

Interventions

Nicotine ReplacementDRUG

Received NRT (Electronic Cigarette - With Nicotine)

Questionnaire AdministrationOTHER

Ancillary studies

Electronic CigaretteDEVICE

Electronic Cigarette - with Nicotine

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Cigarettes Per Day

Mean cigarettes per day (CPD) smoked during the phase

Time frame: 2 weeks

Secondary Outcomes

Electronic Cigarette Sessions Per Day

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

Time frame: 2 weeks

Total Nicotine Equivalents (TNE)

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.

Time frame: 2 weeks

Anabasine

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.

Time frame: 2 weeks

Nicotelline

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.

Time frame: 2 weeks

Perceived Health Risk Questionnaire (PHRQ)

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.

Time frame: 2 weeks

Product Evaluation Scales (PES)

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.

Data from ClinicalTrials.gov

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Electronic Cigarette -without Nicotine

Implicit Association Test (IAT)

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

Time frame: 2 weeks

Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)

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

Time frame: 2 weeks

Purchase Task Breakpoint Measure

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.

Time frame: 2 weeks

Purchase Task Demand Intensity Measure

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

Time frame: 2 weeks

Purchase Task Omax Measure

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

Time frame: 2 weeks

Purchase Task Pmax Measure

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

Time frame: 2 weeks

Purchase Task Elasticity of Demand Measure

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

Time frame: 2 weeks

Fagerström Test for Cigarette Dependence (FTCD)

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

Time frame: 2 weeks

Penn State Electronic Cigarette Dependence Index (PSECDI)

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

Time frame: 2 weeks

Minnesota Nicotine Withdrawal Scale-Revised (MNWS)

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

Time frame: 2 weeks

Questionnaire of Smoking Urges-Brief (QSU-Brief)

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

Time frame: 2 weeks

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

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

Time frame: 2 weeks

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

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

Time frame: 2 weeks

Smartphone Daily Measures of Nicotine Dependence Symptoms

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

Time frame: 2 weeks

American Thoracic Society Questionnaire (ATSQ)

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

Time frame: 2 weeks