Baby Albert: Electronic Cigarette Pharmacokinetics (PK) and Abuse Liability
Condition: Tobacco Use
Study type: Observational

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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A sample of up to 30 current cigarette smokers and dual e-cigarette and cigarette users who
        are willing to use/try an alternative nicotine-delivery device will be recruited via
        advertisements/ recruitment materials (e.g., craigslist, ads on OSU, OU, and UCO campuses,
        OUHSC, email) and referrals. Participants will live in the Oklahoma City, OK metro area.
        Participants will be provided information about the study and provide initial consent for
        screening via an online screener.
      
Biospecimen description: 
      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.
    
Keywords: e-cigarettes; juul brand e-cigarette; njoy brand e-cigarette; evolv/mirage DNA 75c brand e-cigarette