Acceptability of Less Harmful Alternatives to Cigarettes

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(s) in this Clinical Trial

• Behavioral: telephone-based intervention
• Drug: nicotine replacement therapy
• Other: informational intervention
• Other: internet-based intervention
• Other: questionnaire administration

Primary Measures

• Percent of participants with no interest in trial of harm-reduction products (HRPs)
  • Safety Issue?: No
• Percent of participants willing to try HRPs
  • Safety Issue?: No
• Percent of participants that completed 1-week trial
  • Safety Issue?: No
• Percent of participants willing to continue with preferred HRP
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Roswell Park Cancer Institute Other

Overall Clinical Trial Officials and Contacts

Martin Mahoney, MD Principal Investigator Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00957424

Study ID Number: CDR0000648665

ClinicalTrials.gov Identifier: NCT00957424

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database