E-Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users
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|ClinicalTrials.gov Identifier: NCT03943706|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Investigation of Electronic Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Exclusive cigarette smokers
Exclusive cigarette smokers must smoke at least 10 cigarettes per day for the past three months and have exhaled carbon monoxide (eCO) levels of at least 6 ppm at the screening visit.
Dual (Electronic cigarette and cigarette smoking) users
Dual e-cigarette and cigarette users must have smoked at least 5 cigarettes per day for the last 3 months and use e-cigarettes at least 15 days per month for the last 3 months.
- Nicotine delivery measured by serum (blood) nicotine [ Time Frame: 1 month ]Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes, usual brand cigarette and Very Low Nicotine Cigarettes (VLNCs). Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.
- Proportion of puffs earned and allocated to each product in three hypothetical tobacco regulatory scenarios [ Time Frame: 1 month ]Participants will complete three computer tasks simulating hypothetical regulatory scenarios and will earn and allocate puffs to study products. A greater proportion of puffs allocated will indicate greater demand for the product in that hypothetical scenario
Biospecimen Retention: Samples Without DNA
During their PK (Pharmacokinetics) visits, Blood will be collected during specific time points and plasma will be extracted from the blood. Plasma will be used to analyze the levels of nicotine in it.
Urine will be collected from female participants in order to confirm their pregnancy status. Saliva will be collected during their screening visit to analyze for cotinine levels in order to check their smoking status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943706
|Contact: Theodore Wagener, PhD||405-271-8001 ext firstname.lastname@example.org|
|Contact: Toral R Mehta, PhD||405-271-8001 ext 50497||Toral-Mehta@ouhsc.edu|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center Oklahoma Tobacco Research Center||Not yet recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Theodore Wagener 405-271-8001 ext 50486 email@example.com|
|Principal Investigator:||Theodore Wagener, PhD||University of Oklahoma|