Acceptability of Less Harmful Alternatives to Cigarettes

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Liver Cancer; Pancreatic Cancer; Kidney Cancer; Leukemia; Tobacco Use Disorder; Bladder Cancer; Esophageal Cancer; Cervical Cancer; Gastric Cancer
• Interventions: Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: informational intervention; Other: internet-based intervention; Other: questionnaire administration

• Registration Number: NCT00957424
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Study Completion: 2011-11
• Results First Submitted: 2016-10-19
• Results First Submitted QC: 2016-10-19
• Status Verified: 2016-12
• Results First Posted: 2016-12-14
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall	informational intervention	Single-armed study
Overall	internet-based intervention	Single-armed study
Overall	nicotine replacement therapy	Single-armed study
Overall	telephone-based intervention	Single-armed study
Overall	questionnaire administration	Single-armed study

Primary Outcome Measures

Name	Time	Method
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)	Baseline
Number of Participants That Completed 1-week Trial	One week
Number of Participants Willing to Try HRPs	Baseline
Number of Participants Willing to Continue With Preferred HRP	1 week follow up

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States