Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Currently smokes ≥ 10 cigarettes per day

• Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days

• Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria

PATIENT CHARACTERISTICS:

• Not pregnant or nursing

• Able to read and speak English

• In good general health

• No history of heart attack or stroke in the past 2 weeks

• No history of chest pains in the past month

• No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker

• No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma

PRIOR CONCURRENT THERAPY:

• No other concurrent tobacco products or nicotine medications

• No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication

Trial Contact Information

Trial Lead Organizations/Sponsors

Roswell Park Cancer Institute

Martin Mahoney

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00957424
Information obtained from ClinicalTrials.gov on March 05, 2012

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