Evaluating New Nicotine Standards for Cigarettes - Project 3
Condition: Smoking, Cigarette; Electronic Cigarettes
Study type: Interventional

Summary: 
      This study is designed to examine how the nicotine content of cigarettes and the nicotine
      concentration and flavors in e-liquids influence responses to and use of these products in
      adolescent smokers. Participants will complete a total of six sessions (an in-person
      screening/baseline session and five lab sessions.
    

Detailed description: 
      Adolescence is a critical developmental period for tobacco initiation and progression to
      regular use and dependence. The Food and Drug Administration (FDA) has the authority to
      establish standards for tobacco products for the protection of public health, including the
      authority to mandate a reduction in the nicotine content of all cigarettes to minimally
      addictive levels. Numerous studies have found that adult smokers who are switched to very low
      nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake,
      nicotine dependence and abstinence-induced craving relative to those who use normal nicotine
      content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are
      limited and more information is needed to inform potential product standards. Furthermore,
      use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has
      increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in
      youth should be examined in the context of vaping device availability. This study is designed
      to examine how the nicotine content of cigarettes and the nicotine concentration and flavors
      in e-liquids influence responses to these products in adolescents.

      Participants will complete an in-person baseline session in which eligibility criteria are
      confirmed and background questionnaires are completed. Next, participants will complete five
      in-person lab sessions in which NNC or VLNC cigarettes are available (based on random
      assignment). During the first lab session, participants will test the assigned research
      cigarettes when no alternative product is available. During each of the four remaining lab
      sessions, smokers' responses to the assigned research cigarettes will be compared to their
      responses to a vaping device with the following characteristics: 1) no nicotine, tobacco
      flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco
      flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after
      sampling and rating the subjective effects of the products available during that session,
      participants will make a series of 10 choices. Choices will be for either 2 puffs of the
      research cigarette, 2 puffs of the vaping device, or abstinence from puffing.
    

Intervention name(s): Spectrum Research Cigarettes
Intervention type(s): Behavioral
Intervention description(s): Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Mixed between subjects and within-subjects design. Random assignment to the between subjects factor (nicotine content in cigarettes), within-subjects manipulation of nicotine concentration and flavors in e-liquid in the electronic cigarettes
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Smoking; Cigarettes; E-Cigarettes