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

NCT01800500 | Terminated

• 2 other identifiers: I 165309NCI-2013-00403
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (4)

• Proportion of tobacco use accounted for by ST

  Tested using hierarchical linear modeling and generalized estimating equations.

  Up to week 5

• Proportion of group members that replace at least 50% of baseline cigarette consumption with ST

  Assessed using a Fisher's exact test.

  Up to week 5

• Change in saliva cotinine

  Tested using hierarchical linear modeling and generalized estimating equations.

  Up to week 5

• Change in exhaled alveolar CO

  Tested using hierarchical linear modeling and generalized estimating equations.

  Up to week 5

Study Arms (2)

Arm I (fixed rate ST product prices)

EXPERIMENTAL

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; Other: questionnaire administration; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: ecigarettes

Arm II (escalating ST product prices)

EXPERIMENTAL

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; Other: questionnaire administration; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: ecigarettes

Interventions

smoking cessation intervention BEHAVIORAL

Purchase ST products using a fixed rate of product prices

Arm I (fixed rate ST product prices)

questionnaire administration OTHER

Ancillary studies

Arm I (fixed rate ST product prices); Arm II (escalating ST product prices)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (fixed rate ST product prices); Arm II (escalating ST product prices)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (fixed rate ST product prices); Arm II (escalating ST product prices)

ecigarettes OTHER

Purchase ST products using escalating product prices nicotine replacement therapy

Also known as: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT

Arm II (escalating ST product prices)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Martin Mahoney

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 27, 2013
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)