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

18 Years
Not Enrolling
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

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Trial Information

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



- 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.


- 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

- 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

Inclusion Criteria


- 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


- 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


- No other concurrent tobacco products or nicotine medications

- No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Percent of participants with no interest in trial of harm-reduction products (HRPs)

Outcome Time Frame:

A 10-15 minute web-based survey on a computer

Safety Issue:


Principal Investigator

Martin Mahoney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 2009

Completion Date:

November 2011

Related Keywords:

  • Bladder Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Tobacco Use Disorder
  • tobacco use disorder
  • bladder cancer
  • cervical cancer
  • esophageal cancer
  • gastric cancer
  • renal cell carcinoma
  • adult primary liver cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • pancreatic cancer
  • hypopharyngeal cancer
  • laryngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • oropharyngeal cancer
  • paranasal sinus and nasal cavity cancer
  • adult acute myeloid leukemia
  • Urinary Bladder Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Leukemia
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Tobacco Use Disorder



Roswell Park Cancer InstituteBuffalo, New York  14263