NCT05072925

BIDI Stick ENDS Abuse Liability and Puffing Topography Assessment

Abuse Liability and Puffing Topography Assessments of the BIDI Stick Electronic Nicotine Delivery System (ENDS) in Comparison to a Combustible Cigarette and JUUL Pod-Based ENDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: BIDI Vapor · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study assessed the abuse liability (measured by assessing how much nicotine enters the body when the BIDI Stick is used, and how this makes users feel) and puffing topography (puff characteristics like volume and duration) of the BIDI Stick ENDS, a type of electronic cigarette.

Detailed description

This is a part-randomized, open label abuse liability assessment (ALA) and puffing topography study of nicotine-containing products carried out in 18 healthy adult volunteers who smoke combustible cigarettes. Subjects will attend the study site 8 times (Visits 2-9) during the main study for ALA and puff topography assessments. Prior to each visit, subjects will be required to refrain from using any nicotine-containing products for a period of at least 12 hours before study product use. At Visit 2, the subjects will smoke their usual brand cigarette during 2 use sessions. In the first session, subjects will smoke a single combustible cigarette of their usual brand by taking 10 puffs, 30 seconds apart. Blood samples will be obtained for plasma nicotine analysis, and blood pressure and heart rate will be recorded. Subjects will be asked to complete subjective effects questionnaires at various points either before, during, or after product use. In the second session, which will begin immediately after the last blood draw following the first session and after all questionnaires have been completed, subjects will be allowed to take ad libitum puffs on their usual brand cigarette for a period of 60 minutes (1 hour). In a randomly-selected subset of 8 subjects, during this ad libitum puffing session puffing topography measurements will be made with a CReSS Pocket device. Subjects may smoke as many cigarettes as they like. In all subjects, a blood sample for nicotine PK analysis will be drawn at the end of the session. Blood pressure and heart rate will be recorded at this time. Subjective effects questionnaires will also be completed at specified timepoints. At Visits 3-9, the subjects will use their randomly-assigned ENDS product during 2 use sessions. These use sessions, and the assessments made, will be the same as at visit 2. Prior to visit 3-9, subjects will be provided with a supply of their randomly-assigned product to use at home before their next visit (familiarization). This familiarization period should last a minimum of 2 and a maximum of 5 days.

Conditions

• E-cigarette Use
• Cigarette Smoking

Interventions

Type	Name	Description
OTHER	Tobacco products	Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions

Timeline

• Start date: 2021-07-07
• Primary completion: 2021-07-23
• Completion: 2021-07-23
• First posted: 2021-10-11
• Last updated: 2021-10-11

Locations

1 site across 1 country: Poland