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

Tobacco Use Disorder Clinical Trial

Official title:

Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01800500
• Other study ID #: I 165309
• Secondary ID: NCI-2013-00403
• Status: Terminated
• Phase: N/A
• Start date: September 2011

Study information

• Verified date: September 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• smoking cessation intervention
Purchase ST products using a fixed rate of product prices
• smoking cessation intervention
Purchase ST products using escalating product prices

Other:
• questionnaire administration
Ancillary studies
• quality-of-life assessment
Ancillary studies
• laboratory biomarker analysis
Correlative studies
• ecigarettes
Purchase ST products using escalating product prices nicotine replacement therapy
• ecigarettes
Purchase ST products using a fixed rate of product prices nicotine replacement therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of tobacco use accounted for by ST	Tested using hierarchical linear modeling and generalized estimating equations.	Up to week 5
Primary	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
Primary	Change in saliva cotinine	Tested using hierarchical linear modeling and generalized estimating equations.	Up to week 5
Primary	Change in exhaled alveolar CO	Tested using hierarchical linear modeling and generalized estimating equations.	Up to week 5