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Acceptability of Less Harmful Alternatives to Cigarettes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957424
First Posted: August 12, 2009
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) [ Time Frame: Baseline ]
  • Number of Participants Willing to Try HRPs [ Time Frame: Baseline ]
  • Number of Participants That Completed 1-week Trial [ Time Frame: One week ]
  • Number of Participants Willing to Continue With Preferred HRP [ Time Frame: 1 week follow up ]

Enrollment: 67
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Overall
Single-armed study
Behavioral: telephone-based intervention
10-15 minute web-based survey on a computer
Drug: nicotine replacement therapy
One week supply
Other: informational intervention Other: internet-based intervention Other: questionnaire administration
Given out week 2, 3 and 4.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957424


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Martin Mahoney, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00957424     History of Changes
Other Study ID Numbers: CDR0000648665
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-I-118207
First Submitted: August 11, 2009
First Posted: August 12, 2009
Results First Submitted: October 19, 2016
Results First Posted: December 14, 2016
Last Update Posted: February 7, 2017
Last Verified: December 2016

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases