Acceptability of Less Harmful Alternatives to Cigarettes

December 14, 2016 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Overall
Single-armed study
Other: internet-based intervention
Other: informational intervention
Behavioral: telephone-based intervention
10-15 minute web-based survey on a computer
Drug: nicotine replacement therapy
One week supply
Other: questionnaire administration
Given out week 2, 3 and 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Time Frame: Baseline
Baseline
Number of Participants Willing to Try HRPs
Time Frame: Baseline
Baseline
Number of Participants That Completed 1-week Trial
Time Frame: One week
One week
Number of Participants Willing to Continue With Preferred HRP
Time Frame: 1 week follow up
1 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Martin Mahoney, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000648665
  • P30CA016056 (U.S. NIH Grant/Contract)
  • RPCI-I-118207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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