The study will assess product use behaviors, biomarkers of exposure, subjective effects, and safety in smokers who switch to a RELX ENDS over 8-weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
194
Ad libitum use of the RELX ENDS Tobacco Flavor product
Ad libitum use of the RELX ENDS Menthol product
Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products
Pillar Clinical Research
Bentonville, Arkansas, United States
AMR - Lexington
Lexington, Kentucky, United States
QPS
Springfield, Missouri, United States
AMR - Las Vegas
Las Vegas, Nevada, United States
Weekly RELX ENDS product use
Self-reported number of RELX ENDS pods started each week.
Time frame: 56 days
Daily number of cigarettes smoked
Self-reported number of cigarettes smoked daily by study week.
Time frame: 56 days
Number of puffs from the RELX ENDS each day
Self-reported number of puffs from the RELX ENDS daily by study week (0, \< 100, ≥ 100 per day).
Time frame: 56 days
Biomarkers of exposure measured in blood
Change in carbon monoxide concentration in the blood.
Time frame: Baseline, Day 28, and Day 56
Biomarkers of tobacco exposure measured in urine
Change in creatinine-adjusted NNAL, NNN, 3-HPMA, CEMA, HMPMA, S-PMA, HEMA, 1-OHP, o-toluidine, nicotine equivalents, and propylene glycol excreted in urine.
Time frame: Baseline, Day 28, and Day 56
Subjective effects as measured by the Penn State [Electronic] Cigarette Dependence Index (PS[E]CDI)
Change in product dependence as measured by the PSCDI/PSECDI total score. Total scores may range for 0 to 20, with higher levels of dependence associated with higher scores.
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Cough Questionnaire
Change in self-reported cough symptoms as measured by responses to the Cough Questionnaire.
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
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AMR - Knoxville
Knoxville, Tennessee, United States
Subjective effects as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Change in smoking urge as measured by the QSU-Brief factor 1 and factor 2 scores. Questionnaire responses are measured on a Likert scale range of 1 \[not at all\] to 7 \[extremely\].
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Change in withdrawal symptoms as measured by the MTWS-R total score, which includes the DSM-5 and craving items from the Minnesota Tobacco Withdrawal Scale. Questionnaire responses are measured on a Likert scale range of 0 \[none\] to 4 \[severe\]).
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Modified Product Evaluation Scale (mPES)
Change in product assessments as measured by mPES satisfaction, psychological reward, aversion, and relief subscale scores. Questionnaire responses are measured on a Likert scale range of 1 \[not at all\] to 7 \[extremely\].
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Future Intent to Use Questionnaire
Change in future intent to use cigarettes and ENDS products as measured by responses to the Future Intent to Use Questionnaire. Questionnaire responses are measured on a Likert scale range of 1 \[extremely unlikely\] to 7 \[extremely likely\].
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective Effects as measured by the Health Effects Perceptions Questionnaire
Harmful and addictiveness perceptions as measured by responses to the Health Effects Perceptions Questionnaire.
Time frame: Baseline and Day 56
Puff topography - number of puffs
Change in the number of puffs during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
Puff topography - puff duration
Change in puff duration during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
Puff topography - puff volume
Change in puff volume during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
Puff topography - peak puff flow rate
Change in peak puff flow rate during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
Puff topography - average flow rate
Change in average flow rate during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
Puff topography - inter-puff interval
Change in inter-puff interval during a 1-hour puff topography session.
Time frame: Baseline, Day 28, and Day 56
RELX ENDS product use
Change in pod weight during a 1-hour topography session
Time frame: Day 28 and Day 56
Incidence of product-use emergent adverse events [Safety and Tolerability]
Incidence of product-use emergent adverse events
Time frame: 56 days