Study in Adult Smokers to Evaluate Changes in Biomarkers of Tobacco
Research type
Research Study
Full title
A Randomised, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Tobacco Exposure After Switching to Exclusive Use of the JUUL2 System
IRAS ID
303912
Contact name
Samuel Israel
Contact email
Sponsor organisation
Juul Labs Inc.
ISRCTN Number
ISRCTN27662176
Duration of Study in the UK
0 years, 3 months, 17 days
Research summary
This will be a randomised, open-label, parallel-group study in adult smokers to be conducted at multiple sites in the United Kingdom. Changes in biological makers from baseline when using 1 of 2 flavours of JUUL2 System, 18 mg/mL nicotine, relative to exclusive-use of combustible cigarettes, will be assessed as the primary objective in this study. These changes, relative to tobacco nicotine abstinence, will also be assessed as a secondary objective.
Participants who successfully complete the screening procedures, including a brief trial with the JUUL2 System containing 18 mg/mL nicotine, will be eligible to return to the study site on Day -2 (Check-in) for Baseline assessments. Baseline assessments will occur from Check-in (Day -2) through the morning of Day 1 prior to the start of randomised product use. Participants will be considered enrolled upon completion of all screening activities including study product familiarisation and training and meeting all study eligibility (inclusion/exclusion) criteria. All participants will continue to smoke their usual brand of cigarettes freely through the evening (through normal waking hours) of Day -2 (Check-in) and for 15 hours (± 15 minutes) on Day -1.
Participants will be randomized into 1 of 4 study groups. Participants will either exclusively use the assigned JUUL2 System freely, exclusively smoke their usual brand of cigarettes freely, or undergo tobacco/nicotine abstinence for 6 consecutive days beginning on Day 1. Each participant will participate in 1 study group only. Each study group will consist of approximately 24 participants.
Blood samples will be collected on the evenings of Day -1 and Day 6 and 24-hour urine samples starting on Day -1 and Day 6 will be collected for biomarker assessment as mentioned above. Participants will be discharged after completion of study procedures on Day 7.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0187
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion