Trial record 3 of 67 for:
"Tobacco, Smokeless" | Open Studies
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
This study is currently recruiting participants.
Verified February 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01800500
First received: February 20, 2013
Last updated: February 26, 2013
Last verified: February 2013
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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 2013 (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
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: | February 26, 2013 |
| 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 May 22, 2013