Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT07267195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 single-site, open-label, randomized, 8-way crossover study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]), during and following ad libitum use of the study investigational products (IPs) by generally healthy adult smokers.
Detailed Description:
Smokers who predominantly smoke non-menthol (Arm 1) and menthol (Arm 2) combustible cigarettes will be recruited into this AL study.
Potential participants will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on Day -1, participants will check-in at the clinical site to complete procedures to re-confirm eligibility. Eligible participants will be enrolled and confined for 10 days. Participants will be randomized to one of 8 product use sequences using a Williams Design. Starting on Day 1, for each product use sequence, participants will evaluate one IP in each of eight separate daily test sessions, each following a 12-hour period of abstinence from all tobacco- and nicotine-containing products. At the end of all the test sessions each participant will have evaluated the six HTP IPs, including: three non-menthol IPs - arm 1; three menthol IPs - arm 2 using either a one-component (device 1) or two-component (device 2) HTP device. Participants will also evaluate both a high-AL comparator (participant's usual brand \[UB\] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy \[NRT\] gum \[Nicorette® White Ice Mint, 4 mg nicotine; referred to hereafter as "NRT gum"\]).
On Day 1 and continuing through Day 9, participants in both arms will participate in daily test sessions that will last for approximately 4 hours. Each test session will include collection of both PD (subjective and physiological) and PK measures, during and following IP use.
For both study arms, and approximately half a day prior to each respective Test Session, a Product Acclimation Period will allow participants ad libitum use of subsequent IP (\~5 minutes for device1/device 2 IPs, \~30 minutes for NRT per use) at least twice as per randomized sequence for product familiarization prior to use in the next day's Test Session. Following each Product Acclimation Period, participants will have access to their UB cigarettes for ad libitum smoking until the 12-hour tobacco abstinence begins prior to each Test Session.
Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests.
The Medical Monitor will be available for consultation throughout the duration of the study and for any follow-ups after study discharge.
Potential participants will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on Day -1, participants will check-in at the clinical site to complete procedures to re-confirm eligibility. Eligible participants will be enrolled and confined for 10 days. Participants will be randomized to one of 8 product use sequences using a Williams Design. Starting on Day 1, for each product use sequence, participants will evaluate one IP in each of eight separate daily test sessions, each following a 12-hour period of abstinence from all tobacco- and nicotine-containing products. At the end of all the test sessions each participant will have evaluated the six HTP IPs, including: three non-menthol IPs - arm 1; three menthol IPs - arm 2 using either a one-component (device 1) or two-component (device 2) HTP device. Participants will also evaluate both a high-AL comparator (participant's usual brand \[UB\] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy \[NRT\] gum \[Nicorette® White Ice Mint, 4 mg nicotine; referred to hereafter as "NRT gum"\]).
On Day 1 and continuing through Day 9, participants in both arms will participate in daily test sessions that will last for approximately 4 hours. Each test session will include collection of both PD (subjective and physiological) and PK measures, during and following IP use.
For both study arms, and approximately half a day prior to each respective Test Session, a Product Acclimation Period will allow participants ad libitum use of subsequent IP (\~5 minutes for device1/device 2 IPs, \~30 minutes for NRT per use) at least twice as per randomized sequence for product familiarization prior to use in the next day's Test Session. Following each Product Acclimation Period, participants will have access to their UB cigarettes for ad libitum smoking until the 12-hour tobacco abstinence begins prior to each Test Session.
Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests.
The Medical Monitor will be available for consultation throughout the duration of the study and for any follow-ups after study discharge.
Study Oversight
Has Oversight DMC:
False
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?: