Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Tobacco Use Disorder
Behavioral: smoking cessation intervention
Other: questionnaire administration
Other: quality-of-life assessment
Other: laboratory biomarker analysis
Other: ecigarettes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: September 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: smoking cessation intervention
Purchase ST products using a fixed rate of 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 a fixed rate of product prices nicotine replacement therapy
Other Name: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01800500

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Richard O'Connor    877-275-7724    Richard.O'Connor@roswellpark.org   
Principal Investigator: Martin C. Mahoney         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Martin Mahoney Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01800500     History of Changes
Other Study ID Numbers: I 165309, NCI-2013-00403
Study First Received: February 20, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014