Acceptability of Less Harmful Alternatives to Cigarettes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00957424
First received: August 11, 2009
Last updated: March 5, 2012
Last verified: March 2012
  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:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Percent of participants with no interest in trial of harm-reduction products (HRPs) [ Time Frame: A 10-15 minute web-based survey on a computer ] [ Designated as safety issue: No ]
  • Percent of participants willing to try HRPs [ Time Frame: A 10-15 minute web-based survey on a computer ] [ Designated as safety issue: No ]
  • Percent of participants that completed 1-week trial [ Time Frame: One week ] [ Designated as safety issue: No ]
  • Percent of participants willing to continue with preferred HRP [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: telephone-based intervention
    10-15 minute web-based survey on a computer
    Drug: nicotine replacement therapy
    One day supply
    Other: informational intervention Other: internet-based intervention Other: questionnaire administration
    Given out week 2, 4 and 6.
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
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
Investigators
Principal Investigator: Martin Mahoney, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00957424     History of Changes
Other Study ID Numbers: CDR0000648665, P30CA016056, RPCI-I-118207
Study First Received: August 11, 2009
Last Updated: March 5, 2012
Health Authority: United States: Federal Government

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:
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Uterine Cervical Neoplasms
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 Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014