Acceptability of Less Harmful Alternatives to Cigarettes

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
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
Study Start Date :	June 2009
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	November 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

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 ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	August 12, 2009
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:

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; Tobacco Use Disorder; 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