Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036105 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm design | Experimental | On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nicotine pouch - 2 mg | Other | "On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma nicotine concentration | Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline | Baseline to the end of the session, approximately 4 hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change physical sensations | The Direct Effects of Nicotine Questionnaire (DEN) is used to assess the extent to which product use affects participants physically. It consists of 10 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. | Baseline to the end of the session, approximately 4 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Breland, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Single arm study
Not provided
Not provided
Not provided
Not provided
| oral nicotine pouch - 4 mg | Other | "On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor |
|
| oral nicotine pouch - 8 mg | Other | "On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor |
|
| Smokeless tobacco | Other | Participant's typical brand of smokeless tobacco |
|
| Change in sensations and emotions |
The Direct Effects of Smokeless Tobacco (DESLT) Questionnaire is used to assess sensations and emotions associated with smokeless tobacco use. It consists of 12 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. |
| Baseline to the end of the session, approximately 4 hours |
| Change emotions and urges | The Hughes-Hatsukami Questionnaire (HH) is used to assess the extent to which product use affects a variety of emotions and urges. It consists of 11 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. | Baseline to the end of the session, approximately 4 hours |