NCT00957424

Acceptability of Less Harmful Alternatives to Cigarettes

International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Cervical Cancer
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Cancer
• Kidney Cancer
• Leukemia
• Liver Cancer
• Lung Cancer
• Pancreatic Cancer
• Tobacco Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	telephone-based intervention	10-15 minute web-based survey on a computer
DRUG	nicotine replacement therapy	One week supply
OTHER	informational intervention
OTHER	internet-based intervention
OTHER	questionnaire administration	Given out week 2, 3 and 4.

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-08-01
• Completion: 2011-11-01
• First posted: 2009-08-12
• Last updated: 2017-02-07
• Results posted: 2016-12-14

Locations

1 site across 1 country: United States