Acceptability of Less Harmful Alternatives to Cigarettes
Condition: Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Tobacco Use Disorder
Study type: Interventional

Summary: 
      RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and
      nicotine replacement therapy may be useful in helping smokers stop smoking.

      PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to
      cigarettes.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the impact of factual information (a fact sheet) about the relative harms of
           smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about
           relative harmfulness.

        -  To assess the impact of trying samples of NR and/or SL products on intentions to use
           such products as alternatives to cigarettes.

      Secondary

        -  To explore the effects of factual information in regard to smoked tobacco on smokers'
           intentions to use such products as alternatives to cigarettes.

        -  To assess potential barriers to use of both NR and SL products as substitutes for
           cigarettes.

        -  To obtain estimates of possible effect sizes for powering a proposed comprehensive test
           of the likely outcomes of using these products in preference to cigarettes (and other
           smoked products).

      OUTLINE:

      Participants undergo a 10-15 minute web-based survey on a computer in the Tobacco Research
      Laboratory to assess basic demographic information; beliefs about the relative harmfulness of
      nicotine replacement (NR) and smokeless (SL) products, including use of relevant questions
      from the International Tobacco Control (ITC) 4 country survey; past experiences with NR and
      SL products and perceptions about them; and willingness to try samples of NR/SL products they
      have not previously used, or, if not willing, reasons for refusal. Participants also receive
      an information sheet while simultaneously hearing an audio recording of it.

      Participants complete questionnaires at 2, 3, and 4 weeks.

      Beginning 2 weeks after study intervention, some participants receive a day's supply of ≤ 4
      smokeless tobacco or nicotine products and periodically undergo a breath CO and saliva and
      buccal cell sample collection. Surveys are completed and samples collected at 3 and 4 weeks.
    

Intervention name(s): telephone-based intervention; nicotine replacement therapy; informational intervention; internet-based intervention; questionnaire administration
Intervention type(s): Behavioral; Drug; Other; Other; Other
Intervention description(s): 10-15 minute web-based survey on a computer; One week supply; Given out week 2, 3 and 4.
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: tobacco use disorder; bladder cancer; cervical cancer; esophageal cancer; gastric cancer; renal cell carcinoma; adult primary liver cancer; non-small cell lung cancer; small cell lung cancer; pancreatic cancer; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; adult acute myeloid leukemia