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
Received NRT (Electronic Cigarette - With Nicotine)
Ancillary studies
Electronic Cigarette - with Nicotine
M D Anderson Cancer Center
Houston, Texas, United States
Cigarettes Per Day
Mean cigarettes per day (CPD) smoked during the phase
Time frame: 2 weeks
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.
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Electronic Cigarette -without Nicotine
Time frame: 2 weeks
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