This is an observational, crossover study that will be examine use behaviors, chemical exposures, and biological effects of SREC compared to TC use in subjects confined to a research ward setting.
Daily cigarette smokers who are familiar with e-cigarette (EC) use will be instructed to use only NIDA Standardized Research Electronic Cigarettes (SREC) and tobacco cigarettes (TC) while enrolled on the study. Our overall goals are two-fold: (1) to compare nicotine and toxicant exposure and pharmacological effects of SREC used alone vs tobacco cigarettes alone (TC), or dual use; and (2) using SREC alone, TC alone, or ad libitum SREC use combined with 50% reduction in usual TC use as a model for dual use, to examine the extent to which nicotine and toxicant exposure and biomarkers of potential harm compare among the 3 groups. The former would inform the effects of total switching, the latter would inform the potential harm reducing effects of smoking fewer TC while using EC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank: * Sealed and disposable * Minimum 350 puffs per tank * Volume of e-liquid per tank \~ 3ml E-Liquid Characteristics: * Tobacco flavored * Nicotine concentration: 15 mg/ml * Propylene Glycol:\~ 50% (wt / wt) * Glycerin: \~ 50% (wt / wt) * Cotinine: \<1 μg/g * Nornicotine: 5 μg/g * Myosmine : 3 μg/g * Anabasine: \<1 μg/g * Anatabine: \<1 μg/g * Beta:nicotyrine: \<1 μg/g * Diacetyl: \<2 μg/g * 2,3:Pentanedione: \<1 μg/g * Arsenic: \<0.1 μg/g * Cadmium: \<0.1 μg/g * Chromium: \<0.1 μg/g * Lead: \<0.1 μg/g * Nickel: \<0.1 μg/g * Mercury: \<0.05 μg/g
UCSF Tobacco Research Center
San Francisco, California, United States
Peak Nicotine Concentration
Compare peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
Time frame: Up to 2 years
Time of Peak Nicotine Concentration
Compare time of peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
Time frame: Up to 2 years
Mean overall systemic nicotine exposure
Descriptive statistics will be used to examine systemic nicotine exposure from daily use of SREC and compare daily nicotine intake to TC use
Time frame: Baseline through study completion, approximately 2 years
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
The mCEQ use three multi-item domains (subscales) and two single items: "Smoking Satisfaction", "Psychological Reward", "Aversion", "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction". Scores for each subscale are calculated as the average of its individual item responses of The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking. Scores will be compared between SREC, TC, and dual use
Time frame: Baseline through study completion, approximately 2 years
Patterns of puffing
Compare the pattern of puffing between SREC and TC use by coding the recorded ad libitum use of SREC vs TC.
Time frame: Baseline through study completion, approximately 2 years
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
The MTWS-R features two separate measures for examining the severity of nicotine withdrawal symptoms in a participant: a self-report scale and an observer scale. The observer scale asks the scale-taker to rate the severity of four symptoms in someone the they know who is experiencing nicotine withdrawal: "angry/irritable/frustrated," "anxious/tense," "depressed," and "restless/impatient." The self-report version asks for rankings of the severity of those same four symptoms, plus eleven others that cannot be observed by outsiders (including such things as "desire or craving to smoke," "insomnia, sleep problems, awakening at night," or "dizziness). Both scales use a Likert-type scale for the severity ratings, ranging from 0 ("not at all") to 4 ("severe"). These scores are tallied to calculate an a total withdrawal discomfort score and will be compared between SREC, TC, and dual use.
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Time frame: Baseline through study completion, approximately 2 years
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and total scores are calculated by summing the item scores to compare craving between SREC, TC, and dual use.
Time frame: Baseline through study completion, approximately 2 years
Change in Mean score on the Positive and Negative Affect Scale (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame and the final score is derived out of the sum of the ten items on both the positive and negative side. Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The scores will be comparted between SREC, TC, and dual use.
Time frame: Baseline through study completion, approximately 2 years
Changes in mean circadian heart rate
Compare changes in mean circadian heart rate between SREC-only and TC-only use
Time frame: Baseline through study completion, approximately 2 years
Changes in mean blood pressure
Compare changes in blood pressure between SREC-only and TC-only use
Time frame: Baseline through study completion, approximately 2 years
Changes in mean urinary catecholamine
Compare mean urinary catecholamine excretion between SREC-only and TC-only use
Time frame: Baseline through study completion, approximately 2 years
Mean Level of exposure to Tobacco smoke toxicant
Compare levels of exposure of tobacco smoke toxicant between dual SREC-TC use and TC-only use
Time frame: Baseline through study completion, approximately 2 years
Sensitivity of anabasine or nicotelline to nicotine metabolites
Sensitivity is defined as the ratio of anabasine or nicotelline to nicotine metabolites (cotinine or total nicotine equivalents) in urine from SREC-only and TC-only use.
Time frame: Baseline through study completion, approximately 2 years
Specificity of anabasine or nicotelline to nicotine metabolites
Specificity of anabasine or nicotelline will be compared to nicotine metabolites (cotinine or total nicotine equivalents) in urine from SREC-only and TC-only use.
Time frame: Baseline through study completion, approximately 2 years