Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356610
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-12
Brief Title:
Pharmacokinetic and Subjective Effects of Heated Tobacco Products
Sponsor:
Altria Client Services LLC
Organization:
Altria Client Services LLC
Study Overview
Official Title:
A Randomized Controlled Six-way Crossover Clinical Study To Characterize The Nicotine Pharmacokinetics And Subjective Effects Of Four Heated Tobacco Products In Adult Menthol And Nonmenthol Cigarette Smokers
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled six-way crossover clinical study to characterize the nicotine PK pharmacokinetic and subjective effects of HTPs Heated Tobacco Products comprised of 2 menthol varieties and 2 tobacco flavor varieties Ploom HTPs Japan Tobacco Inc in adult menthol and non-menthol combustible cigarette smokers males and females between the ages of 22 and 65 The study will include participants UBCC Usual Brand Combustible Cigarette and a nicotine gum Nicorette as high and low abuse liability reference products respectively to the HTP Study participation is expected to last up to 34 days including a 28-day screening period that includes a 5-day at-home HTP product trial period and a 6-day in-clinic confinement period from Check-in Day -1 through the end-of-study EOS visit on Day 6
Detailed Description:
This is a randomized controlled six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs 2 menthol varieties Products A and B 2 tobacco flavor varieties Products C and D in adult menthol and non-menthol combustible cigarette smokers The study will include participants UBCC Product F and a nicotine gum Product E as high and low abuse liability reference products respectively to the HTP The study will include generally healthy adult males and females who smoke factory manufactured combustible cigarettes This study will recruit approximately 60 participants composed of approximately 30 menthol and 30 non-menthol adult smokers in an attempt to obtain approximately 48 study completed participants approximately 24 menthol and 24 non-menthol smokers Adult participants will be between 22 and 65 years of age at screening inclusive Participants must have a history of smoking 10 to 30 menthol or non-menthol cigarettes daily for at least 12 months prior to screening
Enrolled participants will be randomized based on sex and their UBCC menthol or non-menthol to one of 6 product use sequences
Screening will occur within 28 days prior to Day 1 and includes administering the FTCD Fagerstrom Test for Cigarette Dependence standard safety procedures collection of baseline information and a 5-day at-home HTP product trial period
Enrollment visit Day -6 will occur 5 days prior to Check-in Day -1 Participants will receive the Ploom HTP products for at-home product acclimation to become familiar with the product during the next 5 days Training on how to use the Ploom HTP device will be provided to each participant at the Enrollment visit Participants will receive all four varieties of HTS on Day -6 and begin the at-home product trial Participants are required to use each HTS variety at least once a day ad libitum for a minimum of 20 HTS uses over 5 days
Participants will check-in on the morning of Day -1 Product use sequence randomization and assignment will also occur on Day -1 Participants will be randomized based on sex and their UBCC menthol or non-menthol to one of six product use sequences Once participants are randomized to a product use sequence product use sessions in confinement will start Participants will remain in confinement at the clinic until completion of all study activities on Day 6
Starting on Day -1 following Check-in through Day 5 depending on the randomized product use sequence participants will use their assigned product HTP UBCC or nicotine gum during an afternoon product use session Participants will use the same assigned product to be tested during the next days morning ad libitum product use PK test session eg if a participant is assigned to Product A HTP as the product to be used in the morning ad libitum product use PK test session on Day 1 the participant will use Product A HTP during the afternoon product use session on Day -1 The afternoon product use session should be no more than approximately 6 hours long Participants will be required to use the assigned study product at least once but no more than six HTS UBCC or nicotine gum ad libitum per daily afternoon product use sessions Participants will then be required to abstain from any tobacco- or nicotine-containing products for at least 12 hours prior to the start of the following mornings ad libitum product use PK test session Morning ad libitum product use PK test sessions will occur on the mornings of Days 1 2 3 4 5 and 6 for a total of 6 morning ad libitum product use PK test sessions
During the morning ad libitum product use PK test session participants will use the assigned study product per their assigned product use sequence Participants will use a single UBCC or HTP for 5 minutes ad libitum or use the nicotine gum for 30 minutes per product use instruction Blood samples for PK will be collected prior to and for 3 hours following the start of each morning ad libitum product use PK test session Heart rate measurements will be taken at specified time points during each morning ad libitum product use PK test session In addition participants will complete subjective effects questionnaires Product Liking TobaccoNicotine Withdrawal Direct Effects of Product Use Product Again and mCEQ at designated time points during each morning ad libitum product use PK test session Participants will remain in confinement starting with Check-in on Day -1 until discharge after all study activities are completed on Day 6 Participants will not be forced to use the tobacconicotine products at any time during the study
Enrolled participants will be randomized based on sex and their UBCC menthol or non-menthol to one of 6 product use sequences
Screening will occur within 28 days prior to Day 1 and includes administering the FTCD Fagerstrom Test for Cigarette Dependence standard safety procedures collection of baseline information and a 5-day at-home HTP product trial period
Enrollment visit Day -6 will occur 5 days prior to Check-in Day -1 Participants will receive the Ploom HTP products for at-home product acclimation to become familiar with the product during the next 5 days Training on how to use the Ploom HTP device will be provided to each participant at the Enrollment visit Participants will receive all four varieties of HTS on Day -6 and begin the at-home product trial Participants are required to use each HTS variety at least once a day ad libitum for a minimum of 20 HTS uses over 5 days
Participants will check-in on the morning of Day -1 Product use sequence randomization and assignment will also occur on Day -1 Participants will be randomized based on sex and their UBCC menthol or non-menthol to one of six product use sequences Once participants are randomized to a product use sequence product use sessions in confinement will start Participants will remain in confinement at the clinic until completion of all study activities on Day 6
Starting on Day -1 following Check-in through Day 5 depending on the randomized product use sequence participants will use their assigned product HTP UBCC or nicotine gum during an afternoon product use session Participants will use the same assigned product to be tested during the next days morning ad libitum product use PK test session eg if a participant is assigned to Product A HTP as the product to be used in the morning ad libitum product use PK test session on Day 1 the participant will use Product A HTP during the afternoon product use session on Day -1 The afternoon product use session should be no more than approximately 6 hours long Participants will be required to use the assigned study product at least once but no more than six HTS UBCC or nicotine gum ad libitum per daily afternoon product use sessions Participants will then be required to abstain from any tobacco- or nicotine-containing products for at least 12 hours prior to the start of the following mornings ad libitum product use PK test session Morning ad libitum product use PK test sessions will occur on the mornings of Days 1 2 3 4 5 and 6 for a total of 6 morning ad libitum product use PK test sessions
During the morning ad libitum product use PK test session participants will use the assigned study product per their assigned product use sequence Participants will use a single UBCC or HTP for 5 minutes ad libitum or use the nicotine gum for 30 minutes per product use instruction Blood samples for PK will be collected prior to and for 3 hours following the start of each morning ad libitum product use PK test session Heart rate measurements will be taken at specified time points during each morning ad libitum product use PK test session In addition participants will complete subjective effects questionnaires Product Liking TobaccoNicotine Withdrawal Direct Effects of Product Use Product Again and mCEQ at designated time points during each morning ad libitum product use PK test session Participants will remain in confinement starting with Check-in on Day -1 until discharge after all study activities are completed on Day 6 Participants will not be forced to use the tobacconicotine products at any time during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None