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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00403 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Difficulty accruing
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking cessation intervention | Behavioral | Purchase ST products using a fixed rate of product prices |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Martin Mahoney | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| smoking cessation intervention | Behavioral | Purchase ST products using escalating product prices |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Other | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| ecigarettes | Other | Purchase ST products using escalating product prices nicotine replacement therapy |
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| ecigarettes | Other | Purchase ST products using a fixed rate of product prices nicotine replacement therapy |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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