Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06312 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA276696 | 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
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.
PRIMARY OBJECTIVES:
I. Assess the abuse liability of e-liquids with and without the presence of synthetic cooling agents.
II. Determine the impact of synthetic cooling agents and flavor on EC puffing behavior (topography).
III. Determine the exposure ranges (harmful and potentially harmful constituents [HPHCs], other toxicants) from vaping e-liquids with and without the presence of synthetic cooling agents.
OUTLINE:
Participants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes. Participants use the e cigarettes for vaping followed by ad libitum vaping. Participants also complete surveys and undergo biosample collection throughout the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruit flavored e-cigarette with synthetic cooling agents added | Active Comparator | Synthetic cooling agents will be added to fruit flavored e-liquid for this condition. |
|
| Fruit flavored e-cigarette | Active Comparator | Fruit flavored e-liquid will be used for this condition. |
|
| Tobacco flavored e-cigarette with synthetic cooling agents added | Active Comparator | Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition. |
|
| Tobacco flavored e-cigarette | Active Comparator | Tobacco flavored e-liquid will be used for this condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Receive and use flavored e-cigarettes (EC) as directed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction and psychological reward | Satisfaction and psychological reward of e-cigarette (EC) vaping will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using e-cigarettes on a scale from 0 (Not at all) - 6 (Extremely). | Minute 5 of vaping session, Minute 35 of vaping session |
| Sensory perceptions of EC vaping experience | Sensory perceptions of EC vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always). | Pre-vaping session |
| E-cigarette puff topography | Will be measured with a topography device that records frequency, duration, and flow rate of EC puffs. These measures are combined to inform overall EC puff behavior. | 35 Minute Vaping session |
| Levels of HPHC and other toxicant exposure from vaping e-liquids | Topography data collected for all participants for each of the conditions vaped will be averaged to produce four human-derived puffing regimens. Machine vaping will be conducted for each of the four e-liquids using the associated human-derived puffing regimens to determine the range of HPHCs and other toxicants in mainstream EC vapor. | After completion of sessions, estimated 4 years |
| Appeal and Sensory | Participants will rate appeal (e.g., liking, disliking) and sensory attributes (e.g., harshness, coolness) outcomes on Visual Analogue Scales (range, 0-100). | Minute 5 of vaping session, Minute 35 of vaping session |
| Measure | Description | Time Frame |
|---|---|---|
| Economic demand breakpoint | The price point at which a participant is no longer willing to pay for a puff of the study e-liquid will be determined by an EC purchase task questionnaire. | Minute 35 of vaping session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alayna P Tackett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
Not provided
| Label | URL |
|---|---|
| The Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator. Participants and data collection staff will be blinded to the order/conditions administered at each trial. The sequence list and subsequent participant ID numbers will be kept separate from data collection staff and will only be accessible by staff who will not be interacting with participants.
Not provided
Not provided
Participants and study staff will be blinded to the study conditions delivered at each visit.
| Biospecimen Collection | Other | Undergo biosample sample collection |
|
|
| Survey Administration | Other | Complete surveys |
|
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |