Acceptability of Less Harmful Alternatives to Cigarettes - Full Text View

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: Open Label
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 lung cancer

Genetic and Rare Diseases Information Center resources: Primary Liver Cancer Esophageal Cancer Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Renal Cell Carcinoma Stomach Cancer Nasopharyngeal Carcinoma Laryngeal Cancer Hypopharyngeal Cancer Oral Cancer Lip and Oral Cavity Cancer

U.S. FDA Resources

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


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

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, see Learn About Clinical Studies.

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


Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00957424 History of Changes
Other Study ID Numbers:	CDR0000648665 P30CA016056 ( US NIH Grant/Contract Award Number ) RPCI-I-118207
Study First Received:	August 11, 2009
Results First Received:	October 19, 2016
Last Updated:	December 14, 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 Stomach Neoplasms Pancreatic 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 Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases

ClinicalTrials.gov processed this record on May 25, 2017