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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
| RAI Services Company | INDUSTRY |
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The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three menthol electronic cigarettes versus combustible menthol cigarettes and nicotine gum.
This study will assess various elements that may provide information regarding the potential for menthol electronic cigarettes (e-cigarettes) to be adopted by current smokers. These various elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of pulse rate and blood pressure, and c) subjective effects measured by Urge to Smoke, Urge for Product, Product Rating, Intent to Use Product Again, and Product Effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Own Brand Menthol Cigarette | Active Comparator | Own Brand Menthol Cigarette |
|
| Electronic Menthol Cigarette #1 | Experimental | VUSE® (menthol flavor, 14 mg nicotine) |
|
| Electronic Menthol Cigarette #2 | Experimental | VUSE® (menthol flavor, 29 mg nicotine) |
|
| Electronic Menthol Cigarette #3 | Experimental | VUSE® (menthol flavor, 36 mg nicotine) |
|
| Leading U.S. Nicotine Gum | Active Comparator | 4 mg nicotine polacrilex gum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Own Brand Menthol Cigarette | Other | combustible menthol cigarette brand style smoked most frequently by subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine area under the plasma nicotine concentration versus time curve (AUC) | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine maximum plasma nicotine concentration (Cmax), baseline adjusted | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine time to maximum plasma nicotine concentration (Tmax), baseline-adjusted | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for Urge to Smoke (UTS) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a numeric rating scale (NRS) to determine area under the UTS score-versus-time curve [area under the effect curve (AUEC)] | -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for Intent to Use Again (IUA) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine area under the IUA score-versus-time curve (AUEC) | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum change in blood pressure relative to baseline | Determine the maximum change in blood pressure | Baseline and at timed intervals over 360 minutes following initiation of IP use |
| Subjective effects scores for Urge for Product (UFP) with respect to initiation of in-clinic IP use (e-cigarettes and nicotine gum only) following a 12-hour tobacco and nicotine abstinence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gartner, MD | Celerion | Principal Investigator |
| Charles Tomek, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29725702 | Result | Stiles MF, Campbell LR, Jin T, Graff DW, Fant RV, Henningfield JE. Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum. Psychopharmacology (Berl). 2018 Jul;235(7):2077-2086. doi: 10.1007/s00213-018-4904-x. Epub 2018 May 3. |
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| Electronic Menthol Cigarette #1 | Other | VUSE® Digital Vapor Cigarette (menthol flavor, 14 mg nicotine) |
|
| Electronic Menthol Cigarette #2 | Other | VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine) |
|
| Electronic Menthol Cigarette #3 | Other | VUSE® Digital Vapor Cigarette (menthol flavor, 36 mg nicotine) |
|
| Leading U.S. Nicotine Gum | Other | 4 mg nicotine polacrilex gum |
|
| Subjective effects scores for Product Ratings (PR) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine area under the PR score-versus-time curve (AUEC) | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Subjective effects scores for Positive Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine area under the Positive PE score-versus-time curve (AUEC) | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Subjective effects scores for Negative Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine area under the Negative PE score-versus-time curve (AUEC) | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Maximum change in pulse rate relative to baseline | Determine the maximum change in pulse rate | Baseline and at timed intervals over 360 minutes following initiation of IP use |
| Baseline cotinine measured pre-IP use | Evaluate changes in baseline cotinine to assess whether subjects substantially changed their nicotine uptake during the study | -0.5 minute (baseline) and -5 min (back-up baseline) for each IP |
| Change in expired carbon monoxide (ECO) relative to baseline | Assess change in ECO from baseline following IP use | Baseline and 35 minutes post-IP use |
| Subjective effects scores for UTS with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine minimum UTS score | -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for UTS with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine time to minimum UTS score | -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for IUA with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine maximum IUA score | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Subjective effects scores for PR with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine maximum PR score | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Subjective effects scores for Positive PE with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine maximum Positive PE score | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
| Subjective effects scores for Negative PE with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine maximum Negative PE score | 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes |
Score subjective effects using a NRS to determine area under the UFP score-versus-time curve (AUEC) |
| -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for UFP with respect to initiation of in-clinic IP use (e-cigarettes and nicotine gum only) following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine maximum UFP score | -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for UFP with respect to initiation of in-clinic IP use (e-cigarettes and nicotine gum only) following a 12-hour tobacco and nicotine abstinence | Score subjective effects using a NRS to determine time to maximum UFP score | -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes |
| Perform CYP2A6 genotyping | A) Assess the impact of CYP2A6 genotype on nicotine uptake and subjective effects following a 12-hour tobacco and nicotine abstinence and B) Explore a potential relationship between CYP2A6 genotype and phenotype | Once, at time of randomization |
| Perform phenotyping (i.e., nicotine metabolic ratio of cotinine:3-hydroxy cotinine) | A) Assess the impact of phenotypic ratio on nicotine uptake and subjective effects following a 12-hour tobacco and nicotine abstinence and B) Explore a potential relationship between CYP2A6 genotype and phenotype | Once, at time of randomization |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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