Acceptability of Less Harmful Alternatives to Cigarettes

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957424
• Other study ID #: CDR0000648665
• Secondary ID: P30CA016056RPCI-
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: June 19, 2015
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: June 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bladder Cancer
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Tobacco Use Disorder
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• telephone-based intervention
10-15 minute web-based survey on a computer

Drug:
• nicotine replacement therapy
One day supply

Other:
• informational intervention

• internet-based intervention

• questionnaire administration
Given out week 2, 4 and 6.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants with no interest in trial of harm-reduction products (HRPs)		A 10-15 minute web-based survey on a computer	No
Primary	Percent of participants willing to try HRPs		A 10-15 minute web-based survey on a computer	No
Primary	Percent of participants that completed 1-week trial		One week	No
Primary	Percent of participants willing to continue with preferred HRP		6 months follow up	No