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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | 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 study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.
As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low nicotine, tobacco | Experimental | 6 mg nicotine combined with tobacco flavored e-juice |
|
| Low nicotine, menthol | Experimental | 6 mg nicotine combined with menthol flavored e-juice |
|
| Low nicotine,cherry | Experimental | 6 mg nicotine combined with cherry flavored e-juice |
|
| High nicotine, tobacco | Experimental | 18 mg nicotine combined with tobacco flavored e-juice |
|
| High nicotine, menthol | Experimental | 18 mg nicotine combined with menthol flavored e-juice |
|
| High Nicotine, cherry | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Nicotine level (6 or 18 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Score in Liking/Wanting of E-cigarette | The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale [range -100 to 100] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking) | Baseline (+10 minutes) to end of lab session (+40 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC, Substance Abuse Center | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Nicotine | 18 mg nicotine |
| FG001 | Low Nicotine | 6mg/ml nicotine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants included in the primary analyses (those who were enrolled in the updated study design October 2020).
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Nicotine Group (6mg/ml) | Participants that were assigned to the low nicotine condition and exposed to tobacco, menthol, cherry, and vanilla. |
| BG001 | High Nicotine Group (18mg/ml) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change Score in Liking/Wanting of E-cigarette | The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale [range -100 to 100] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking) | The study started in May 2019 and the study was active between May 2019 and October 2020 and 9 participants were enrolled. However, due to study changes communicated previously, analyses only reflect enrolled participants who completed the study following the study protocol change (i.e., addition of a laboratory session in October 2020). Randomized non-starters were excluded from analyses (n=8, 5 low nicotine, 3 high nicotine). Those who completed at least one lab had data included in analyses | Posted | Least Squares Mean | Standard Error | units on scale | Baseline (+10 minutes) to end of lab session (+40 minutes) |
|
Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vanilla Low Nicotine Group (6mg/ml) | Participants who were assigned to the low nicotine condition and were exposed to vanilla flavor. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant stepped on nail between Lab 1 and Lab 2. Participant was treated with antibiotics. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Davis | Yale University School of Medicine | 2039747607 | danielle.davis@yale.edu |
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| 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 | Apr 12, 2023 | Jul 5, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2023 | Feb 13, 2024 | ICF_000.pdf |
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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 |
|---|---|
| D009538 | Nicotine |
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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18 mg nicotine combined with cherry flavored e-juice
|
| Low Nicotine, Vanilla | Experimental | 6 mg nicotine combined with vanilla flavored e-juice |
|
| High Nicotine, Vanilla | Experimental | 18 mg nicotine combined with vanilla flavored e-juice |
|
| Flavor | Drug | Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
|
Participants that were assigned to the high nicotine condition and exposed to tobacco, menthol, cherry, and vanilla.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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6 mg nicotine combined with tobacco flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG001 | Low Nicotine, Menthol | 6 mg nicotine combined with menthol flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG002 | Low Nicotine,Cherry | 6 mg nicotine combined with cherry flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG003 | High Nicotine, Tobacco | 18 mg nicotine combined with tobacco flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG004 | High Nicotine, Menthol | 18 mg nicotine combined with menthol flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG005 | High Nicotine, Cherry | 18 mg nicotine combined with cherry flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG006 | Low Nicotine, Vanilla | 6 mg nicotine combined with vanilla flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
| OG007 | High Nicotine, Vanilla | 18 mg nicotine combined with vanilla flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla) |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Vanilla High Nicotine Group (18mg/ml) | Participants who were assigned to the high nicotine condition and were exposed to vanilla flavor. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Cherry Low Nicotine Group (6mg/ml) | Participants who were assigned to the low nicotine condition and were exposed to cherry flavor. | 0 | 51 | 0 | 51 | 1 | 51 |
| EG003 | Cherry High Nicotine Group (18mg/ml) | Participants who were assigned to the high nicotine condition and were exposed to cherry flavor. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG004 | Tobacco Low Nicotine Group (6mg/ml) | Participants who were assigned to the low nicotine condition and were exposed to tobacco flavor. | 0 | 59 | 0 | 59 | 1 | 59 |
| EG005 | Tobacco High Nicotine Group (18mg/ml) | Participants who were assigned to the high nicotine condition and were exposed to tobacco flavor. | 0 | 57 | 0 | 57 | 0 | 57 |
| EG006 | Menthol Low Nicotine Group (6mg/ml) | Participants who were assigned to the low nicotine condition and were exposed to menthol flavor. | 0 | 59 | 0 | 59 | 0 | 59 |
| EG007 | Menthol High Nicotine Group (18mg/ml) | Participants who were assigned to the high nicotine condition and were exposed to menthol flavor. | 0 | 56 | 0 | 56 | 0 | 56 |
| EG008 | Randomized Non-Starter Low Nicotine Group (6mg/ml) | Participants who were randomized to the low nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure | 0 | 8 | 0 | 8 | 0 | 8 |
| EG009 | Randomized Non-starter High Nicotine Group (18mg/ml) | Participants who were randomized to the high nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure | 0 | 6 | 0 | 6 | 0 | 6 |
|
| Other | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant reported minor throat irritation from e-cigarette |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |