Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448351
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-22
Brief Title:
Manipulating E-Cigarette Nicotine to Promote Public Health
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Manipulating E-Cigarette Nicotine to Promote Public Health
Status:
RECRUITING
Status Verified Date:
2024-06
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 clinical trial explores the manipulation of e-cigarette EC nicotine to promote public health Researchers are trying to understand and gather information about how the strength form and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction how people puff on ECs how the body processes nicotine and any potential harmful effects it might have on health Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users
Detailed Description:
PRIMARY OBJECTIVES
I Assess the pharmacological metabolic and behavioral impact of nicotine dimensions Study 1 II Assess the toxicity resulting from different nicotine dimension combinations Study 1 III Across ecologically valid nicotine concentrations and isomer ratios determine free-base FB nicotine fractions with minimal appeal to young adult EC users but sufficient appeal to smokers Study 2
OUTLINE
Phase 1 STUDY 1 Participants are randomized to the order of 8 e-liquid combinations varying in nicotine concentration form and isomer
Participants participate in a 10-puff vaping session over 5 minutes with a study e-liquid using the study EC device followed by a 60 minute washout period and then an ad libitum puffing session over 60 minutes at each lab visit Patients are also given a new pre-filled study device corresponding to the study e-liquid they will use for the subsequent visit to practice at home Puffing sessions continue with a new study e-liquid at each of the 8 lab visits lasting up to 4 hours each Participants also undergo carbon monoxide CO testing and blood and urine sample collection on study
Phase 2 STUDY 2 Participants are randomized to the order of 20 e-liquid combinations varying in concentration FB fractions and isomer
Participants will take part in a 2-puff vaping session with each of the 20 study e-liquids using the study EC device with a 10-minute washout period between each vaping session Vaping sessions are grouped into two blocks of 10 separated by a 30 minute resting session over one lab visit lasting up to 6 hours Participants also undergo CO testing and blood and urine sample collection on study
I Assess the pharmacological metabolic and behavioral impact of nicotine dimensions Study 1 II Assess the toxicity resulting from different nicotine dimension combinations Study 1 III Across ecologically valid nicotine concentrations and isomer ratios determine free-base FB nicotine fractions with minimal appeal to young adult EC users but sufficient appeal to smokers Study 2
OUTLINE
Phase 1 STUDY 1 Participants are randomized to the order of 8 e-liquid combinations varying in nicotine concentration form and isomer
Participants participate in a 10-puff vaping session over 5 minutes with a study e-liquid using the study EC device followed by a 60 minute washout period and then an ad libitum puffing session over 60 minutes at each lab visit Patients are also given a new pre-filled study device corresponding to the study e-liquid they will use for the subsequent visit to practice at home Puffing sessions continue with a new study e-liquid at each of the 8 lab visits lasting up to 4 hours each Participants also undergo carbon monoxide CO testing and blood and urine sample collection on study
Phase 2 STUDY 2 Participants are randomized to the order of 20 e-liquid combinations varying in concentration FB fractions and isomer
Participants will take part in a 2-puff vaping session with each of the 20 study e-liquids using the study EC device with a 10-minute washout period between each vaping session Vaping sessions are grouped into two blocks of 10 separated by a 30 minute resting session over one lab visit lasting up to 6 hours Participants also undergo CO testing and blood and urine sample collection on 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05712 | REGISTRY | CTRP Clinical Trial Reporting Program | None |