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Completed

NCT Number: NCT00957424

Acceptability of Less Harmful Alternatives to Cigarettes

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.

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Key information

Conditions

Bladder Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cervical Cancer Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hypopharyngeal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Laryngeal Diseases Laryngeal Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mental Disorders Mouth Diseases Mouth Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Substance-Related Disorders Thoracic Neoplasms Tobacco Use Disorder Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-Based Intervention

Behavioral

10-15 minute web-based survey on a computer

Nicotine Replacement Therapy

Drug

One week supply

Informational intervention

Other

Internet-Based Intervention

Other

Questionnaire Administration

Other

Given out week 2, 3 and 4.

Primary outcomes

  1. Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)

    Time frame: Baseline

  2. Number of Participants Willing to Try HRPs

    Time frame: Baseline

  3. Number of Participants That Completed 1-week Trial

    Time frame: One week

  4. Number of Participants Willing to Continue With Preferred HRP

    Time frame: 1 week follow up

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Aug 12, 2009
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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