Acceptability of Less Harmful Alternatives to Cigarettes - Full Text View

Sponsor:	Roswell Park Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00957424

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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Cervical Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Stomach Cancer

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percent of participants with no interest in trial of harm-reduction products (HRPs) [ Designated as safety issue: No ]
Percent of participants willing to try HRPs [ Designated as safety issue: No ]
Percent of participants that completed 1-week trial [ Designated as safety issue: No ]
Percent of participants willing to continue with preferred HRP [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

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: 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Martin Mahoney, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00957424 History of Changes
Other Study ID Numbers:	CDR0000648665, RPCI-I-118207
Study First Received:	August 11, 2009
Last Updated:	November 17, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

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
Urologic Neoplasms
Urogenital Neoplasms

Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012