Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Juul Electronic cigarette; Very Low Nicotine Cigarettes; Active Nicotine Patch; Placebo Patch
Intervention description: The juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.; These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).; Active nicotine patches, with dosing based on the package insert (>10 cigs/day = 21 mg patch and <11 cigs/day = 14 mg patches).; Placebo patch containing no nicotine.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For this mixed design study, 180 daily adult smokers who are not planning to quit smoking will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNCs; 2) Juul e-cigarettes; or 3) no alternative product. During two different weeks, participants will be asked to switch from their usual cigarettes and use only study products. They will also be asked to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order.
It should be noted that there were no significant within-subject effects (i.e. comparing Juul + Active Patch in Wk 1 and Placebo Patch in Wk 2 vs. JUUL + Placebo Patch in Wk 1 then Active Patch in Wk 2 yielded no significant differences) therefore results are presented as a 3-group parallel design (i.e. Juul + Active vs. Placebo Patch, VLNC + Active vs. Placebo Patch, No Product + Active vs. Placebo Patch).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants will be randomly assigned to Juul, Very Low Nicotine Cigarette, or No Product with no masking of product type. However, participants will be randomly assigned to receive either placebo or active nicotine patch with masking regarding placebo vs active patch.
Enrollment: 209.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal of this research is to understand the potential impact of two new FDA strategies to
      ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce
      the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this
      research will examine how well ANDS and very low nicotine cigarettes (VLNCs) can work alone
      or in combination with the current strategy of providing a safe source of nicotine via
      nicotine replacement medications to reduce use of combustible cigarettes, in real-world
      settings.

      The investigators will enroll 180 daily adult smokers who are not planning to quit smoking
      within the next 30 days into this mixed design study. Participants will be randomly assigned
      to one of three levels of the between-subjects factor: 1) VLNC cigarettes; 2) Juul
      e-cigarettes (with nicotine); or 3) no alternative product. Participants receiving an
      alternative product (VLNC or e-cigarettes) will be asked to use it for 4 weeks (Weeks 1
      through 4). During Weeks 2 and 4 all participants will be asked to switch from their
      cigarettes to use only study products (i.e., Juul e-cigarettes, VLNCs, or no alternative
      product) and to use either an active nicotine or placebo patch (the within-subjects factor),
      provided in double-blind fashion and counterbalanced order. During Weeks 1 through 4,
      participants will use a smartphone to record, in the moment, each time they use their own
      cigarettes or any alternative product. For a random daily subset of use events, participants
      will complete additional questions about the internal and external context of their use
      (e.g., affect, any restrictions on smoking) and their response to use (e.g., withdrawal
      alleviation, taste, satisfaction). Using these data, the investigators will also examine the
      effects of these products on the rewarding value of smoking and possible mechanisms driving
      such behavior (e.g., withdrawal alleviation, satisfaction, taste).

      This research will provide critical information regarding the potential impact of providing
      cigarettes with non-addictive levels of nicotine and safe ANDS, with or without nicotine
      replacement, in real-world settings on smokers' use of their usual cigarettes and other
      outcomes. Information on the short-term effects of products that could be accessible in the
      future will provide data that could inform regulatory policy decisions regarding the public
      health impact of safe ANDS and non-addictive cigarettes.
    

Eligibility criteria:

        Inclusion criteria:

          -  smoking >4 cigarettes/day for the previous 6 months

          -  able to read, write, and speak English

          -  no plans to quit smoking in the next 30 days

          -  not currently taking smoking cessation medication

          -  willing and medically able to use nicotine patches

          -  exhaled carbon monoxide (CO) > 6 ppm.

        Exclusion criteria:

          -  currently in treatment for psychosis or bipolar disorder

          -  e-cigarette use within the last month

          -  currently pregnant or breastfeeding.