NCT03637452

Baby Albert: Electronic Cigarette Pharmacokinetics (PK) and Abuse Liability

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if banning the sale of fully nicotinized cigarettes were to go into effect. A sample of up to 30 current cigarette users (n=15) and dual e-cigarette and combustible cigarette users (n=15) who are willing to try an alternative nicotine-delivery device will be recruited. They will complete the screening visit, visit 1 and 2 preceded by 12 hours of nicotine/tobacco abstinent.

Detailed description

Participants will be provided information about the study and will provide initial consent for screening via an online screener. Written consent will be completed in person when participants are present to the laboratory. Eligible participants will include anyone over the age of 18 years and those who exclusively use combustible cigarettes or those who dual use e-cigarettes and combustible cigarettes. For the exclusive cigarette group, we will allow some e-cigarette experimentation. Participants will complete three in-lab study visits (1 screener visit and 2 study visits) separated by a standard minimum 48-hour washout period. They will be offered an Uber or other rideshare service as transportation to each study visit, however, they will not be required to use the service. Participants will complete an in-person screening visit in which they will be rescreened according to the eligibility criteria. Their exhaled carbon monoxide (eCO) will be checked prior to their visits as well as breath alcohol and urine pregnancy (for females) test will be conducted. Participant will also complete baseline assessment measures and Balloon Analog Risk Task (BART)- computerized task measuring impulsivity. At visit 2, participants will complete a standard 10 puff bout with the three e-cigarette devices and their usual brand cigarette. During visit 3, participants will complete three concurrent choice tasks in a counter-balanced fashion.

Conditions

• Tobacco Use

Timeline

• Start date: 2018-11-12
• Primary completion: 2019-05-23
• Completion: 2019-05-23
• First posted: 2018-08-20
• Last updated: 2020-12-17

Locations

1 site across 1 country: United States