Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco
      flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and
      use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS
      users. In this study will recruit 80 young (18-24) JUUL users, in a 2x2 cross over lab study
      where in one condition they will use their JUUL preferred flavor and the other JUUL standard
      tobacco flavor. Our aims are to; Aim 1: Compare satisfaction, withdrawal suppression, and
      harm perception between tobacco-flavored and preferred flavor JUUL. This analysis will reveal
      the extent to which preferred flavor contributes to smoking satisfaction, withdrawal and
      craving suppression, and harm perception, compared to the standard tobacco flavor.

      Aim 2: Compare puff topography and plasma nicotine levels between tobacco-flavored and
      preferred flavor JUUL. This analysis will examine the extent to which preferred flavor
      contributes to puffing behavior and toxicant exposure compared to the standard tobacco
      flavor.

      Aim 3: Compare exhaled breath condensate (EBC) between tobacco-flavored and preferred flavor
      JUUL. This analysis will be the first to examine exposure to toxic aldehydes (formaldehyde,
      acetaldehyde, acrolein, benzaldehyde, and propionaldehyde) produced when using preferred
      flavor compared to the standard tobacco flavor.

      Utilizing powerful clinical lab methods, this study will provide a broad testing of the
      effect of flavor manipulation on college-aged JUUL users, and provide experimental evidence
      about the potential of flavor-limitation policies on young ENDS users in the US.
    

Detailed description: 
      The use of e-cigarettes, or electronic nicotine delivery systems (ENDS), among adolescents
      and young adults continues to be a major public health issue. Because of appealing design,
      flavor selection, and popularity on social media, JUUL ENDS have gained popularity among
      young people, many of whom are not aware that JUUL devices contain nicotine. Regulating ENDS
      flavor represents a promising approach to curb ENDS use among US youth. This project will
      provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and
      assist public health authorities by providing answers to specific questions pertinent to the
      potential of ENDS regulation through flavor. These include: - How would flavor manipulation
      influence puffing behavior and plasma nicotine levels among JUUL smokers; - how would smoking
      smoking preferred or tobacco flavor reflects on smoker's satisfaction, withdrawal
      suppression, and harm perception; - how would flavor manipulation affect toxicant exposure
      levels measured on exhaled breath condensate (EBC) on JUUL smokers. Answers to these
      questions will help public health authorities predict the impact of flavor regulation on ENDS
      experimentation and continued use.

      Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco
      flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and
      use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS
      users. In this study, we will recruit 80 young (18-24) JUUL users. Each participant will
      undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2)
      one where they will be vaping the standard classic tobacco flavor; 3) a third one in which
      they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a
      health warning label (HWL) attached to it. In addition, 10 participants will be invited to
      come back for two additional sessions: one in which they will be vaping their preferred
      flavor pod with a 3% nicotine concentration, and one in which they will use their preferred
      flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm
      perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.

      In the past few months, there has been an increasing number of reports of severe respiratory
      illness related to e-cigarette use. Both the U.S. Food and Drug Administration and the U.S.
      Centers for Disease Control and Prevention are currently investigating this outbreak.
      According to the CDC, these cases of e-cigarette, or vaping, associated lung injury (EVALI)
      have been reported in most patients that report a history of using THC-containing products,
      particularly those obtained off the street or from other informal sources (e.g. friends,
      family members, illicit dealers)
      (https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html).
      Several steps have been taken to minimize this risk (i.e., excluding marijuana and
      non-commercial vaping products users; excluding individuals with current potential EVALI
      symptoms; revision of the consent & re-consenting of participants that still need to complete
      study sessions; and providing all participants with a CDC fact sheet about EVALI). For
      further details please refer to the "Methods" & "Minimizing Risks" sections.

      This study involves minimal risks (explained in more details below in section 8) to
      participants. These risks are: 1) JUUL use 2) Dependence 3) Venipuncture 4) EVALI risk. The
      risk involved in participating in the JUUL smoking sessions of this study will not exceed the
      risk that would otherwise be encountered during similar recreational sessions of JUUL
      smoking.

      Participants will benefit by being involved in a study that can increase their awareness
      about the health and addictive consequences of JUUL smoking and they will be given
      educational materials at the end of the study that explain the health impact of e-cigarettes,
      the current EVALI outbreak, and include resources that are available to help with quitting
      such as national, state and local cessation services (please see the fact sheets attached in
      the methods section). The findings of this study will benefit the society at large.
      Understanding the effect of flavor manipulation on JUUL/ENDS users will be instrumental for
      local and federal health agencies' potential to curb the spread of ENDS use, and protect
      public health in the US.
    

Intervention name(s): Preferred Juul pod flavor (5% nicotine); Classic Tobacco Juul pod flavor (5% nicotine); Preferred flavor with HWL; Preferred flavor, 3% nicotine; Preferred flavor, 0% nicotine
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Preferred Juul pod flavor (5% nicotine); Classic Tobacco Juul pod flavor (5% nicotine); Preferred flavor (5% nicotine) with HWL; Preferred flavor, 3% nicotine; Preferred flavor, 0% nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.
Masking: None (Open Label)
Primary purpose: Other