Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
Condition: Cigarette Smoking-Related Carcinoma
Study type: Interventional

Summary: 
      This clinical trial studies the effect of free-base compared with nicotine salt based
      e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and
      absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC
      smokers. The results from this study may provide much needed scientific information to public
      health officials and regulators.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To examine the influence of nicotine form on puffing behavior and abuse liability.

      II. To evaluate the influence of nicotine form and concentration on nicotine distribution in
      the brain and respiratory tract.

      OUTLINE:

      VISIT 1: Patients sample 4-liquids to determine whether they can vape the unflavored e-liquid
      without coughing

      Patients are randomized to 1 of 2 arms.

      ARM I:

      VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and
      undergo 0-15 minutes (min) head and 5 min chest positron emission tomography (PET)/computed
      tomography (CT) and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial
      PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid
      and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest
      PET/CT.

      VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and
      undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT.
      About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or
      unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then
      0-15 min head and 5 min chest

      ARM II:

      VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and
      undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT.
      About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or
      unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then
      0-15 min head and 5 min chest.

      VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and
      undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT.
      About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or
      unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15
      min head and 5 min chest PET/CT.
    

Intervention name(s): Cigarette Smoking; Cigarette Smoking; Cigarette Smoking; Cigarette Smoking; Computed Tomography; Positron Emission Tomography; Questionnaire Administration
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Procedure; Procedure; Other
Intervention description(s): Receive 1 puff of tobacco flavored protonated e-liquid; Receive 1 puff of unflavored protonated e-liquid; Receive 1 puff of tobacco flavored unprotonated cigarette; Receive 1 puff of unfavored unprotonated cigarette; Undergo PET/CT; Undergo PET/CT; Ancillary studies
Other intervention name(s): CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT; CT Scan; tomography; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention