Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03206 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young adult EC users | Active Comparator | Young Adult EC users |
|
| Older adult smokers | Active Comparator | Adult smokers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaping study EC A | Behavioral | Vaping two puffs using the study EC device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Intentions for Continued Use | Self-report measure on a 7-point scale completed following e-cigarette self-administration. Ratings range from1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product. | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| Intensity of Sensory Attributes | 5-item self-report measure completed following e-cigarette self-administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity. | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| Degree of Liking or Disliking of Sensations | Self-report measure completed following e-cigarette self-administration, using the Labeled Hedonic Scale (LHS). Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking. | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Appeal | 12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses to the e-cigarettes. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theodore L Wagener, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699050 | Derived | Cho YJ, Brinkman MC, Hinton A, Nshimiyimana JD, Mehta T, Adeniji A, Norton K, El Hellani A, Wagener TL. The sweet spot study-Developing e-liquid product standards for nicotine form and concentration to improve public health: Protocol for a randomized, double-blinded, crossover study. PLoS One. 2023 Sep 12;18(9):e0291522. doi: 10.1371/journal.pone.0291522. eCollection 2023. |
| Label | URL |
|---|---|
| The Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Young Adult EC Users | Guided by study staff, young adult e-cigarette users and older adult smokers took two puffs from each of the 10 study conditions ([5%, 25%, 45%, 65%, 85%] freebase nicotine fractions × [20 mg/mL, 50 mg/mL] nicotine concentrations) using the study e-cigarette device. Each condition was administered in a single vaping session, with a 10-minute washout period between conditions. Participants received pre-filled e-liquid pods in random order and were instructed to inhale each puff for at least one second. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Vaping study EC B | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC C | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC D | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC E | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC F | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC G | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC H | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC I | Behavioral | Vaping two puffs using the study EC device |
|
| Vaping study EC J | Behavioral | Vaping two puffs using the study EC device |
|
| The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| FG001 | Older Adult Smokers | Guided by study staff, young adult e-cigarette users and older adult smokers took two puffs from each of the 10 study conditions ([5%, 25%, 45%, 65%, 85%] freebase nicotine fractions × [20 mg/mL, 50 mg/mL] nicotine concentrations) using the study e-cigarette device. Each condition was administered in a single vaping session, with a 10-minute washout period between conditions. Participants received pre-filled e-liquid pods in random order and were instructed to inhale each puff for at least one second. |
| 20mg/mL Nicotine Concentration, 5% Free-base Fraction Study EC Device |
|
| 20mg/mL Nicotine Concentration, 25% Free-base Fraction Study EC Device |
|
| 20mg/mL Nicotine Concentration, 45% Free-base Fraction Study EC Device |
|
| 20mg/mL Nicotine Concentration, 65% Free-base Fraction Study EC Device |
|
| 20mg/mL Nicotine Concentration, 85% Free-base Fraction Study EC Device |
|
| 50mg/mL Nicotine Concentration, 5% Free-base Fraction Study EC Device |
|
| 50mg/mL Nicotine Concentration, 25% Free-base Fraction Study EC Device |
|
| 50mg/mL Nicotine Concentration, 45% Free-base Fraction Study EC Device |
|
| 50mg/mL Nicotine Concentration, 65% Free-base Fraction Study EC Device |
|
| 50mg/mL Nicotine Concentration, 85% Free-base Fraction Study EC Device |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Young Adult EC Users | Young adult e-cigarette users |
| BG001 | Older Adult Smokers | Older adult cigarette smokers |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Cigarettes Smoked per Day | Mean | Standard Deviation | cigarettes per day |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Behavioral Intentions for Continued Use | Self-report measure on a 7-point scale completed following e-cigarette self-administration. Ratings range from1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product. | Posted | Mean | Standard Deviation | score on a scale | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Intensity of Sensory Attributes | 5-item self-report measure completed following e-cigarette self-administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity. | Participants who provided valid responses to the gLMS items; responses were missing in two instances | Posted | Mean | Standard Deviation | score on a scale | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Degree of Liking or Disliking of Sensations | Self-report measure completed following e-cigarette self-administration, using the Labeled Hedonic Scale (LHS). Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking. | Participants who provided valid responses to the LHS item, LHS data was missing in 7 instances | Posted | Mean | Standard Deviation | score on a scale | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjective Appeal | 12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses to the e-cigarettes. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. | Posted | Mean | Standard Deviation | score on a scale | The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours. |
|
Single study visit, Up to 3 hours
We combined adverse event reporting across arms because no adverse events occurred, making separate reporting by dose level unnecessary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Adult EC Users | Young adult e-cigarette users | 0 | 70 | 0 | 70 | 0 | 70 |
| EG001 | Older Adult Smokers | Older adult cigarette smokers | 0 | 80 | 0 | 80 | 0 | 80 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore L. Wagener | OhioSUCCC | 614-366-4265 | Theodore.Wagener@osumc.edu |
| Jul 31, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Purchase Product for Regular Use |
|
| Use Product Regularly |
|
| Young Adult EC Users - 20mg/mL, 65% Free-base |
Young Adult EC Users - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG004 | Young Adult EC Users - 20mg/mL, 85% Free-base | Young Adult EC Users - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG005 | Young Adult EC Users - 50mg/mL, 5% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG006 | Young Adult EC Users - 50mg/mL, 25% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG007 | Young Adult EC Users - 50mg/mL, 45% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG008 | Young Adult EC Users - 50mg/mL, 65% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG009 | Young Adult EC Users - 50mg/mL, 85% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 85% Free-base fraction |
| OG010 | Older Adult Smokers - 20mg/mL, 5% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 5% Free-base fraction |
| OG011 | Older Adult Smokers - 20mg/mL, 25% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 25% Free-base fraction |
| OG012 | Older Adult Smokers - 20mg/mL, 45% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 45% Free-base fraction |
| OG013 | Older Adult Smokers - 20mg/mL, 65% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG014 | Older Adult Smokers - 20mg/mL, 85% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG015 | Older Adult Smokers - 50mg/mL, 5% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG016 | Older Adult Smokers - 50mg/mL, 25% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG017 | Older Adult Smokers - 50mg/mL, 45% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG018 | Older Adult Smokers - 50mg/mL, 65% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG019 | Older Adult Smokers - 50mg/mL, 85% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 85% Free-base fraction |
|
|
| Young Adult EC Users - 20mg/mL, 65% Free-base |
Young Adult EC Users - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG004 | Young Adult EC Users - 20mg/mL, 85% Free-base | Young Adult EC Users - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG005 | Young Adult EC Users - 50mg/mL, 5% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG006 | Young Adult EC Users - 50mg/mL, 25% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG007 | Young Adult EC Users - 50mg/mL, 45% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG008 | Young Adult EC Users - 50mg/mL, 65% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG009 | Young Adult EC Users - 50mg/mL, 85% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 85% Free-base fraction |
| OG010 | Older Adult Smokers - 20mg/mL, 5% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 5% Free-base fraction |
| OG011 | Older Adult Smokers - 20mg/mL, 25% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 25% Free-base fraction |
| OG012 | Older Adult Smokers - 20mg/mL, 45% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 45% Free-base fraction |
| OG013 | Older Adult Smokers - 20mg/mL, 65% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG014 | Older Adult Smokers - 20mg/mL, 85% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG015 | Older Adult Smokers - 50mg/mL, 5% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG016 | Older Adult Smokers - 50mg/mL, 25% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG017 | Older Adult Smokers - 50mg/mL, 45% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG018 | Older Adult Smokers - 50mg/mL, 65% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG019 | Older Adult Smokers - 50mg/mL, 85% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 85% Free-base fraction |
|
|
| OG003 | Young Adult EC Users - 20mg/mL, 65% Free-base | Young Adult EC Users - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG004 | Young Adult EC Users - 20mg/mL, 85% Free-base | Young Adult EC Users - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG005 | Young Adult EC Users - 50mg/mL, 5% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG006 | Young Adult EC Users - 50mg/mL, 25% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG007 | Young Adult EC Users - 50mg/mL, 45% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG008 | Young Adult EC Users - 50mg/mL, 65% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG009 | Young Adult EC Users - 50mg/mL, 85% Free-base | Young Adult EC Users - 50mg/mL nicotine concentration, 85% Free-base fraction |
| OG010 | Older Adult Smokers - 20mg/mL, 5% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 5% Free-base fraction |
| OG011 | Older Adult Smokers - 20mg/mL, 25% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 25% Free-base fraction |
| OG012 | Older Adult Smokers - 20mg/mL, 45% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 45% Free-base fraction |
| OG013 | Older Adult Smokers - 20mg/mL, 65% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 65% Free-base fraction |
| OG014 | Older Adult Smokers - 20mg/mL, 85% Free-base | Older Adult Smokers - 20mg/mL nicotine concentration, 85% Free-base fraction |
| OG015 | Older Adult Smokers - 50mg/mL, 5% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 5% Free-base fraction |
| OG016 | Older Adult Smokers - 50mg/mL, 25% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 25% Free-base fraction |
| OG017 | Older Adult Smokers - 50mg/mL, 45% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 45% Free-base fraction |
| OG018 | Older Adult Smokers - 50mg/mL, 65% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 65% Free-base fraction |
| OG019 | Older Adult Smokers - 50mg/mL, 85% Free-base | Older Adult Smokers - 50mg/mL nicotine concentration, 85% Free-base fraction |
|
|
|
|
|
|