Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RELX ENDS Tobacco Flavor | Experimental | Switch from combustible cigarettes to RELX ENDS Tobacco Flavor for 56 days |
|
| RELX ENDS Menthol Flavor | Experimental | Switch from combustible cigarettes to RELX ENDS Menthol Flavor for 56 days |
|
| RELX ENDS Tobacco and Menthol Flavors | Experimental | Switch from combustible cigarettes to RELX ENDS Tobacco and Menthol Flavor for 56 days |
|
| Continue-smoking | No Intervention | Continue smoking combustible cigarettes for 56 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELX ENDS Tobacco Flavor | Other | Ad libitum use of the RELX ENDS Tobacco Flavor product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly RELX ENDS product use | Self-reported number of RELX ENDS pods started each week. | 56 days |
| Daily number of cigarettes smoked | Self-reported number of cigarettes smoked daily by study week. | 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). | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of exposure measured in blood | Change in carbon monoxide concentration in the blood. | 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. |
Not provided
Inclusion Criteria:
If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first product use and during the study. An acceptable method of contraception includes one of the following:
If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald Graff, PharmD | Sponsor Representative | Study Director |
| Mark Adams, MD | AMR - Lexington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | United States | ||
| AMR - Lexington |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RELX ENDS Menthol Flavor | Other | Ad libitum use of the RELX ENDS Menthol product |
|
| RELX ENDS Tobacco and Menthol Flavors | Other | Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products |
|
| 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. | 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. | Baseline, Day 14, Day 28, Day 42, and Day 56 |
| 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]. | 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]). | 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]. | 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]. | 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. | Baseline and Day 56 |
| Puff topography - number of puffs | Change in the number of puffs during a 1-hour puff topography session. | Baseline, Day 28, and Day 56 |
| Puff topography - puff duration | Change in puff duration during a 1-hour puff topography session. | Baseline, Day 28, and Day 56 |
| Puff topography - puff volume | Change in puff volume during a 1-hour puff topography session. | 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. | Baseline, Day 28, and Day 56 |
| Puff topography - average flow rate | Change in average flow rate during a 1-hour puff topography session. | Baseline, Day 28, and Day 56 |
| Puff topography - inter-puff interval | Change in inter-puff interval during a 1-hour puff topography session. | Baseline, Day 28, and Day 56 |
| RELX ENDS product use | Change in pod weight during a 1-hour topography session | Day 28 and Day 56 |
| Incidence of product-use emergent adverse events [Safety and Tolerability] | Incidence of product-use emergent adverse events | 56 days |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| QPS | Springfield | Missouri | 65802 | United States |
| AMR - Las Vegas | Las Vegas | Nevada | 89119 | United States |
| AMR - Knoxville | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided