Tobacco-Related Carcinoma Clinical Trial
Official title:
Manipulating E-Cigarette Nicotine to Promote Public Health
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06315881 -
Informing Oral Nicotine Pouch Regulations to Promote Public Health
|
Phase 2 | |
Active, not recruiting |
NCT02964182 -
Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
|
N/A | |
Completed |
NCT04267874 -
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
|
Early Phase 1 | |
Completed |
NCT04510077 -
SmartQuit Program for Smoking Cessation
|
N/A | |
Completed |
NCT03200236 -
The Lung Screening, Tobacco and Health Project
|
Phase 3 | |
Recruiting |
NCT05730439 -
Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
|
Early Phase 1 | |
Recruiting |
NCT04949464 -
Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
|
N/A | |
Not yet recruiting |
NCT06249984 -
Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
|
N/A | |
Enrolling by invitation |
NCT04969978 -
Electronic Quitline Referral With Enhanced Academic Detailing for the Promotion of Smoking Cessation
|
N/A | |
Completed |
NCT05972941 -
Nicotine and Tobacco Message Framing Among LGBT Young Adults
|
N/A | |
Completed |
NCT05453773 -
Hookah Additive Research to Inform Product Standards
|
N/A | |
Withdrawn |
NCT05411107 -
Oral Iloprost for the Prevention of Lung Cancer In Former Smokers
|
Phase 2 | |
Completed |
NCT03268993 -
Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
|
N/A | |
Recruiting |
NCT04340531 -
Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities
|
Phase 4 | |
Terminated |
NCT04297332 -
Episodic Future Thinking and Future Thinking Priming for Smoking Cessation
|
N/A | |
Completed |
NCT03402230 -
Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers
|
Early Phase 1 | |
Recruiting |
NCT05876091 -
Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
|
N/A | |
Completed |
NCT03182959 -
Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer
|
Early Phase 1 | |
Completed |
NCT05393869 -
Evaluating Anti-Tobacco Message Effectiveness Among Lesbian, Gay, Bisexual, and Transgender Young Adults
|
N/A | |
Recruiting |
NCT05679349 -
Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking
|
N/A |