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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01289 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| K01DA055696 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This clinical trial tests the effects of tobacco cut and nicotine form on the abuse liability in participants who use moist snuff (smokeless tobacco [SLT]). Two features of moist snuff that are key targets of manipulation from the tobacco industry and drivers of its addiction potential are length of tobacco cut (long versus fine) and nicotine form (low versus high levels of nicotine in the free-base form). Finer tobacco cuts and higher levels of free-base nicotine (FBN) result in faster, greater nicotine delivery. Researchers want to gain information on how certain characteristics of moist snuff affect how long people use it, how it delivers nicotine, or how much people like it. This clinical trial may provide justifications for local, state, or federal regulations aimed at reducing the appeal and addictiveness of moist snuff.
PRIMARY OBJECTIVES:
I. Estimate the association between style of moist snuff and SLT addiction among Ohio Appalachian adolescents and adults.
II. Characterize the carcinogen and free-base nicotine content of SLT products used by adolescents and adults with varying levels of SLT dependence in Ohio Appalachia.
III. Assess effects of moist snuff tobacco cut and FBN content on product use, effects, and appeal among Appalachian adults with high versus (vs.) low SLT dependence.
OUTLINE: Participants attend 5 study visits in a randomized order.
VISIT I: Participants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
VISIT II: Participants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
VISIT III: Participants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
VISIT IV: Participants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
VISIT V: Participants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (Smokeless tobacco use: Usual Brand) | Placebo Comparator | Participants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. |
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| Prevention (Smokeless tobacco use: Low FBN Long Cut) | Active Comparator | Participants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. |
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| Prevention (Smokeless tobacco use: Low FBN Fine Cut) | Active Comparator | Participants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. |
|
| Prevention (Smokeless tobacco use: High FBN Long Cut) | Active Comparator | Participants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of flavors used by participants | Will be assessed in adolescent and adult participants (expected N=198). Will be evaluated using descriptive statistics | Up to 2 years |
| Associations between tobacco cut (fine, long, and pouches) and level of smokeless tobacco (SLT) dependence | Will use chi-square tests to estimate associations between tobacco cut (fine, long, and pouches) and level of SLT dependence. If the expected cell size for more than 20% of cells is < 5, Fisher's exact test will be used. | Up to 2 years |
| Associations between level of dependence and total nicotine in moist snuff | Descriptive statistics will be calculated and variables will be inspected for out-of-range values. The investigators will merge product characteristics into our cohort study data (e.g., characteristics of Grizzly long cut wintergreen moist snuff will be merged to participants who reported using that style). Next, the investigators will use linear regression to estimate the associations between level of dependence and total nicotine. | Up to 2 years |
| Associations between level of dependence and pH in moist snuff | Descriptive statistics will be calculated and variables will be inspected for out-of-range values. The investigators will merge product characteristics into our cohort study data (e.g., characteristics of Grizzly long cut wintergreen moist snuff will be merged to participants who reported using that style). Next, the investigators will use linear regression to estimate the associations between level of dependence and pH. | Up to 2 years |
| Associations between level of dependence and free-base nicotine (FBN) in moist snuff | Descriptive statistics will be calculated and variables will be inspected for out-of-range values. The investigators will merge product characteristics into our cohort study data (e.g., characteristics of Grizzly long cut wintergreen moist snuff will be merged to participants who reported using that style). Next, the investigators will use linear regression to estimate the associations between level of dependence and FBN in moist snuff. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brittney L Keller-Hamilton, PhD, MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Not yet recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D002248 | Carbon Monoxide |
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Within-subjects factorial design
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Blinded study products
| Prevention (Smokeless tobacco use: High FBN Fine Cut) | Active Comparator | Participants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. |
|
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| Carbon Monoxide Measurement | Procedure | Undergo CO test |
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| Smokeless Tobacco Use | Behavioral | Use moist snuff |
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| Survey Administration | Other | Ancillary studies |
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| Up to 2 years |
| Moist snuff tobacco cut on product use | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of cut on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Moist snuff tobacco FBN content on product use | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of FBN content on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Moist snuff tobacco cut on product effects | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of cut on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Moist snuff tobacco FBN content on product effects | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of FBN content on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Moist snuff tobacco cut on product appeal | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use, nicotine delivery, and subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of cut on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Moist snuff tobacco FBN content on product appeal | Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use, nicotine delivery, and subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of FBN content on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence. | Up to 2 years |
| Center for Tobacco Research | Recruiting | Columbus | Ohio | 43214 | United States |
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| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D062789 | Tobacco Products |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |