Trial record 1 of 1 for:    NCT01800500
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Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers

This study is currently recruiting participants.
Verified January 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01800500
First received: February 20, 2013
Last updated: January 3, 2014
Last verified: January 2014

February 20, 2013
January 3, 2014
September 2011
July 2015   (final data collection date for primary outcome measure)
  • Proportion of tobacco use accounted for by ST [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
    Tested using hierarchical linear modeling and generalized estimating equations.
  • Proportion of group members that replace at least 50% of baseline cigarette consumption with ST [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
    Assessed using a Fisher's exact test.
  • Change in saliva cotinine [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
    Tested using hierarchical linear modeling and generalized estimating equations.
  • Change in exhaled alveolar CO [ Time Frame: Up to week 5 ] [ Designated as safety issue: No ]
    Tested using hierarchical linear modeling and generalized estimating equations.
Same as current
Complete list of historical versions of study NCT01800500 on ClinicalTrials.gov Archive Site
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Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes

This randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Measuring use of other sources of nicotine for cigarettes under a variety of different conditions may help determine whether and how much smokers are willing to use substitutions

PRIMARY OBJECTIVES:

I. Systematically vary price, availability, product type, and information about products to examine their individual and joint effects on degree of substitution of smokeless products for cigarettes.

II. Examine the impact of smokeless tobacco (ST) substitution on biomarkers of exposure (carbon monoxide [CO], cotinine).

III. Explore relationships between ST substitution and measures of mood and health related quality of life.

OUTLINE: Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.

ARM II: Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.

After completion of study treatment, patients are followed up for 6 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Tobacco Use Disorder
  • Behavioral: smoking cessation intervention
    Purchase ST products using a fixed rate of product prices
  • Behavioral: smoking cessation intervention
    Purchase ST products using escalating product prices
  • Other: questionnaire administration
    Ancillary studies
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: ecigarettes
    Purchase ST products using escalating product prices nicotine replacement therapy
    Other Name: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT
  • Other: ecigarettes
    Purchase ST products using a fixed rate of product prices nicotine replacement therapy
    Other Name: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT
  • Experimental: Arm I (fixed rate ST product prices)
    Participants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks
    Interventions:
    • Behavioral: smoking cessation intervention
    • Other: questionnaire administration
    • Other: quality-of-life assessment
    • Other: laboratory biomarker analysis
    • Other: ecigarettes
  • Experimental: Arm II (escalating ST product prices)
    Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
    Interventions:
    • Behavioral: smoking cessation intervention
    • Other: questionnaire administration
    • Other: quality-of-life assessment
    • Other: laboratory biomarker analysis
    • Other: ecigarettes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must report currently smoke at least 10 cigarettes per day and been smoking for at least 1 year
  • Must not be planning to quit smoking in the next 30 days, nor tried to quit in the last 30 days
  • Must be able to read and speak English
  • Should not concurrently using other tobacco products or nicotine medications
  • Willing to try new tobacco products and substitute other brands of cigarettes
  • Not current participating in any other ongoing research study
  • Must be in good general health
  • Medically eligible to receive nicotine replacement products (based upon the New York State [NYS] Smokers Quit line eligibility criteria)

    • No history of heart attack or stoke in last 2 weeks
    • No current use of Zyban, bupropion, Wellbutrin, or Chantix/varenicline, or other smoking cessation medication
    • No history of chest pains or angina in past month
    • No report of physician diagnosed arrhythmia/irregular heartbeat, fast heartbeat, abnormal heart rate, or use of pacemaker
    • No current report of physician diagnosed heart disease/coronary artery disease, high blood pressure (systolic blood pressure [SBP] = 160; diastolic blood pressure [DBP] = 100), stomach ulcer, diabetes, or taking pills for depression or asthma
    • No self-reported chronic dental problems that would interfere with using oral products
    • No use of an electronic cigarette (e-cigarette) in the past 30 days
    • No known sensitivity to glycerol, propylene glycol, or glycerin
  • For females, not currently pregnant or breastfeeding; nor planning to become pregnant during the follow-up interval
  • Prospective participants must also pass screening tests for substance use, administered at the orientation session, to be entered on study; substance use will be assessed using a Clinical Laboratory Improvement Amendments (CLIA)-waived 7-drug urine screen (detecting presence of tetrahydrocannabinol [THC], opiates, amphetamine, barbiturates, methamphetamine, phencyclidine [PCP], and lysergic acid diethylamide [LSD]); participants must test negative on all 7 to be put on study
Both
18 Years and older
No
Not Provided
United States
 
NCT01800500
I 165309, NCI-2013-00403
No
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Martin Mahoney Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP