Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco
Condition: Nicotine Dependence, Cigarettes, Uncomplicated
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Adolescents are an important vulnerable population to consider as the FDA moves toward a
      nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all
      commercially available cigarettes, has the potential to transform public health and greatly
      reduce the toll of tobacco-related death and disease. Yet, data on the effects of such a
      policy on cigarette use among adolescents are lacking. Further, the advent of e-cigarettes
      and the popularity of alternative tobacco products have fundamentally altered the current
      landscape of nicotine delivery, and these products are widely used by adolescents. Although
      adolescent cigarette use is at an all-time low in the U.S., this reduction has been mirrored
      by an increase in e-cigarette use, and multiple tobacco product (MTP) use is the most common
      pattern of use in youth. Adolescent MTP users are more likely to be dependent on nicotine and
      to have begun using tobacco earlier than their single-product using peers. Thus, MTP-using
      youth differ from youth who solely smoke cigarettes in meaningful ways that have implications
      for responses to a nicotine reduction regulatory policy. In adults, longer-term studies have
      demonstrated that very low nicotine content (VLNC) cigarette exposure results in fewer
      cigarettes smoked and reduced toxicant exposure; however, increased use of alternative
      tobacco products has also been reported. No studies to date have examined the effects of VLNC
      cigarettes on MTP use or toxicant exposure in youth. This study will use real-time,
      smartphone-based ecological momentary assessment (EMA) and laboratory-based assessments to:
      (1) investigate the effects of cigarette nicotine reduction on cigarette and MTP use, (2)
      assess the influence of cigarette nicotine reduction on the harms associated with tobacco
      use, including nicotine and toxicant exposure, respiratory symptoms, perceived health risk
      and nicotine dependence, and (3) use a combination of laboratory and real-time assessment to
      investigate the effects of nicotine reduction on changes in withdrawal, craving, and the
      reinforcing efficacy of cigarettes to characterize the mechanisms by which VLNC use may
      affect behavior. Overall, this project will help determine the effects of VLNC cigarettes on
      real-world tobacco use behavior and indices of tobacco-related harm in adolescents, and
      examining the mechanisms through which nicotine reduction in cigarettes may effect such
      changes.
    


Intervention name(s): Very Low Nicotine Content Cigarettes; Normal Nicotine Content Cigarettes
Intervention type(s): Drug; Drug
Intervention description(s): Very Low Nicotine Content Cigarettes; Normal Nicotine Content Cigarettes
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science