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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 electronic cigarettes versus combustible cigarettes and nicotine gum.
This study will assess various elements that may provide information regarding the potential for 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, Product Rating, Intent to Use Product Again, and Product Effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Own Brand Cigarette | Active Comparator | Own Brand Cigarette |
|
| Electronic Cigarette #1 | Experimental | VUSE® (original flavor, 14mg nicotine) |
|
| Electronic Cigarette #2 | Experimental | VUSE® (original flavor, 29mg nicotine) |
|
| Electronic Cigarette #3 | Experimental | VUSE® (original flavor, 36mg nicotine) |
|
| Leading U.S. Nicotine Gum | Active Comparator | Leading U.S. Nicotine Gum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Own Brand Cigarette | Other | combustible 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, 3, 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 IP use following a 12-hour tobacco and nicotine abstinence | Determine maximum plasma nicotine concentration (Cmax), baseline adjusted | -5, -0.5, 3, 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 IP use following a 12-hour tobacco and nicotine abstinence | Determine time to baseline-adjusted maximum plasma nicotine concentration (Tmax) | -5, -0.5, 3, 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)], minimum UTS score, and time to minimum UTS score | -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) and maximum IUA score | 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 |
| Perform both CYP2A6 genotyping and phenotyping (i.e., nicotine metabolic ratio of cotinine:3-OH cotinine) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gartner, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28634710 | Result | Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20. |
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| Electronic Cigarette #1 | Other | VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine) |
|
| Electronic Cigarette #2 | Other | VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine) |
|
| Electronic Cigarette #3 | Other | VUSE® Digital Vapor Cigarette (original flavor, 36mg 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) and maximum PR score | 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) and maximum positive PE score | 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) and maximum negative PE score | 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 |
| 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 |
| Baseline cotinine measured pre-IP use | Evaluate changes in baseline cotinine to assess whether subjects substantially changed their nicotine exposure during the study | -0.5 minute only for each IP, over 5 weeks |
A) Determine the impact of CYP2A6 genotype and phenotype 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 |
| Time of randomization |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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