Lung Cancer Clinical Trial
Official title:
International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study
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.
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: This is a multicenter study.
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 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, 4, and 6 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 4 and 6 weeks.
After completion of study intervention, participants are followed up at 6 months by
telephone.
;
Intervention Model: Single Group Assignment, Masking: Open Label
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