Trial Outcomes & Findings for Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers (NCT NCT05335915)
NCT ID: NCT05335915
Last Updated: 2026-07-23
Results Overview
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product. Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
71 participants
Primary outcome timeframe
0 to 1 hour
Results posted on
2026-07-23
Participant Flow
participants were recruited from the Baltimore community
71 people were enrolled (consented), 43 were ineligible, and 28 were randomized and completed all study conditions.
Participant milestones
| Measure |
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
All participants used nicotine pouches in a within-subject design, in a randomized order. There were 7 conditions, one condition being ad-libitum use of preferred brand cigarette.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
4 mg Original
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28
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Overall Study
8 mg Original
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28
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Overall Study
4 mg Mint
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28
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Overall Study
8 mg Mint
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28
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Overall Study
4 mg Citrus
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28
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Overall Study
8 mg Citrus
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28
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Overall Study
Own-brand Cigarette
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28
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
Baseline characteristics by cohort
| Measure |
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
n=28 Participants
Participants used nicotine pouches in a within-subject design with 7 conditions, with one condition being ad-libitum use of preferred brand cigarette.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=9 Participants
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Age, Categorical
Between 18 and 65 years
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28 Participants
n=9 Participants
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Age, Categorical
>=65 years
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0 Participants
n=9 Participants
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Age, Continuous
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43.6 years
STANDARD_DEVIATION 11.2 • n=9 Participants
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Sex: Female, Male
Female
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11 Participants
n=9 Participants
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Sex: Female, Male
Male
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17 Participants
n=9 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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20 Participants
n=9 Participants
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Race (NIH/OMB)
White
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5 Participants
n=9 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=9 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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Region of Enrollment
United States
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28 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: 0 to 1 hourPopulation: Study completers are reported. 28 participants completed the study.
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product. Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
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Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout)
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6.5 ng/mL
Standard Deviation 3.5
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12.8 ng/mL
Standard Deviation 6.9
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7.2 ng/mL
Standard Deviation 4.2
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11.0 ng/mL
Standard Deviation 7.3
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6.4 ng/mL
Standard Deviation 3.8
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10.8 ng/mL
Standard Deviation 7.9
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14.0 ng/mL
Standard Deviation 8.2
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PRIMARY outcome
Timeframe: 0 to 1 hourPopulation: Results are from all 28 completers.
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Area under the curve (AUC), represents the total nicotine exposure during an entire nicotine use period and provides important insight into the abuse liability of a tobacco product. Data is reported as the mean (SD) change from baseline. Bout 1 (20min directed use) AUC was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
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Pharmacokinetics of Nicotine as Assessed by the AUC (20 Min Directed Bout)
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544.1 ng * min/ml
Standard Deviation 210.1
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930.0 ng * min/ml
Standard Deviation 427.2
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601.7 ng * min/ml
Standard Deviation 249.1
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910.5 ng * min/ml
Standard Deviation 487.4
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638.8 ng * min/ml
Standard Deviation 453.8
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935.1 ng * min/ml
Standard Deviation 511.9
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882.5 ng * min/ml
Standard Deviation 454.8
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PRIMARY outcome
Timeframe: Up to 6.5 hoursPopulation: Results include all 28 completers.
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater liking. Data is reported as mean (SD) change from baseline. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
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Peak Change From Baseline Subjective Ratings of "Like Drug Effect" as Assessed by the Drug Effect Questionnaire
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34.0 score on a scale
Standard Deviation 43.5
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36.8 score on a scale
Standard Deviation 37.0
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23.6 score on a scale
Standard Deviation 29.3
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32.3 score on a scale
Standard Deviation 36.9
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31.8 score on a scale
Standard Deviation 36.7
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31.5 score on a scale
Standard Deviation 35.3
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36.8 score on a scale
Standard Deviation 35.7
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PRIMARY outcome
Timeframe: Up to 6.5 hoursThe DEQ will be used to obtain subjective ratings of "pleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "pleasant drug effect". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
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Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
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Subjective Ratings of "Pleasant Drug Effect" as Assessed by the Drug Effect Questionnaire
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32.4 score on a scale
Standard Deviation 39.7
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38.4 score on a scale
Standard Deviation 38.7
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24.4 score on a scale
Standard Deviation 31.9
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32.2 score on a scale
Standard Deviation 36.9
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31.8 score on a scale
Standard Deviation 36.7
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31.5 score on a scale
Standard Deviation 35.3
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36.8 score on a scale
Standard Deviation 35.7
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PRIMARY outcome
Timeframe: Up to 6.5 hoursThe DEQ will be used to obtain subjective ratings of "take again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "take again" rating. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
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Subjective Ratings of "Take Again" as Assessed by the Drug Effect Questionnaire
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24.8 score on a scale
Standard Deviation 38.4
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23.4 score on a scale
Standard Deviation 32.3
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19.6 score on a scale
Standard Deviation 27.4
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23.8 score on a scale
Standard Deviation 34.0
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28.5 score on a scale
Standard Deviation 37.5
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19.6 score on a scale
Standard Deviation 32.8
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39.3 score on a scale
Standard Deviation 38.2
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PRIMARY outcome
Timeframe: Up to 6.5 hoursThe HHWS will be used to obtain subjective ratings of "urge to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "urge to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
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Subjective Ratings of "Urge to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
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-25.5 score on a scale
Standard Deviation 43.2
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-33.1 score on a scale
Standard Deviation 41.2
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-26.8 score on a scale
Standard Deviation 40.0
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-23.7 score on a scale
Standard Deviation 34.3
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-21.6 score on a scale
Standard Deviation 38.5
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-29.0 score on a scale
Standard Deviation 33.5
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-23.3 score on a scale
Standard Deviation 32.3
|
PRIMARY outcome
Timeframe: Up to 6.5 hoursThe HHWS will be used to obtain subjective ratings of "craving to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "craving to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Subjective Ratings of "Craving to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
|
-26.0 score on a scale
Standard Deviation 40.3
|
-30.0 score on a scale
Standard Deviation 41.8
|
-21.8 score on a scale
Standard Deviation 33.5
|
-27.9 score on a scale
Standard Deviation 38.3
|
-29.1 score on a scale
Standard Deviation 37.5
|
-28.5 score on a scale
Standard Deviation 35.0
|
-25.6 score on a scale
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: Up to1 hourBlood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Time to maximum concentration (Tmax), is the time (in minutes) to reach Cmax. This is another measure relevant for abuse liability. Tmax for bout 1 was calculated based on post-baseline blood timepoints which include 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Nicotine as Assessed by the Tmax
|
26.4 minutes
Standard Deviation 4.9
|
23.9 minutes
Standard Deviation 5.0
|
22.1 minutes
Standard Deviation 6.3
|
24.6 minutes
Standard Deviation 5.8
|
23.6 minutes
Standard Deviation 6.2
|
22.9 minutes
Standard Deviation 7.1
|
15.0 minutes
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Up to 6.5 hoursThe QSU-brief factor 1 (intention to smoke) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 30. Higher scores indicates greater withdrawal symptoms. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 1 (Change From Baseline)
|
-6.9 score on a scale
Standard Deviation 9.1
|
-8.0 score on a scale
Standard Deviation 9.4
|
-6.7 score on a scale
Standard Deviation 8.7
|
-6.3 score on a scale
Standard Deviation 8.9
|
-5.5 score on a scale
Standard Deviation 7.4
|
-6.5 score on a scale
Standard Deviation 7.7
|
-7.4 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 6.5 hoursThe QSU-brief factor 2 (anticipation of relief) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 24. Higher scores indicates greater/worse withdrawal symptoms.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 2 (Change From Baseline)
|
-2.7 score on a scale
Standard Deviation 5.2
|
-3.6 score on a scale
Standard Deviation 6.8
|
-2.7 score on a scale
Standard Deviation 4.0
|
-2.7 score on a scale
Standard Deviation 5.0
|
-2.6 score on a scale
Standard Deviation 3.1
|
-3.5 score on a scale
Standard Deviation 5.6
|
-3.0 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 2 hoursDuring the 2 hour ad libitum bout, topography will be collected. The total time of use (out of 2 hours) will be assessed.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Topography as Assessed by the Total Time of Use
|
49.8 minutes
Standard Deviation 34.4
|
30.5 minutes
Standard Deviation 17.8
|
44.9 minutes
Standard Deviation 28.7
|
39.8 minutes
Standard Deviation 27.6
|
45.1 minutes
Standard Deviation 28.2
|
39.1 minutes
Standard Deviation 29.8
|
—
|
SECONDARY outcome
Timeframe: 6.5 hoursThe DENS will assess nicotine-specific effects. Scores on all items range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher scores indicates stronger (better) nicotine related effects.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Help Calm Down
|
30.8 score on a scale
Standard Deviation 42.1
|
35.0 score on a scale
Standard Deviation 38.5
|
18.8 score on a scale
Standard Deviation 36.2
|
27.2 score on a scale
Standard Deviation 37.9
|
23.7 score on a scale
Standard Deviation 45.5
|
24.4 score on a scale
Standard Deviation 41.0
|
25.4 score on a scale
Standard Deviation 34.3
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Feel More Awake
|
26.2 score on a scale
Standard Deviation 36.2
|
18.4 score on a scale
Standard Deviation 45.0
|
23.2 score on a scale
Standard Deviation 33.5
|
23.0 score on a scale
Standard Deviation 29.4
|
18.3 score on a scale
Standard Deviation 38.8
|
29.0 score on a scale
Standard Deviation 40.1
|
16.2 score on a scale
Standard Deviation 30.8
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Help My Concentration
|
25.2 score on a scale
Standard Deviation 38.8
|
27.8 score on a scale
Standard Deviation 39.4
|
13.6 score on a scale
Standard Deviation 28.1
|
18.1 score on a scale
Standard Deviation 35.3
|
16.5 score on a scale
Standard Deviation 40.7
|
19.8 score on a scale
Standard Deviation 37.6
|
11.9 score on a scale
Standard Deviation 24.4
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Make Me Dizzy
|
7.1 score on a scale
Standard Deviation 16.9
|
6.5 score on a scale
Standard Deviation 16.0
|
6.2 score on a scale
Standard Deviation 14.7
|
11.9 score on a scale
Standard Deviation 16.3
|
5.7 score on a scale
Standard Deviation 28.4
|
1.5 score on a scale
Standard Deviation 9.3
|
5.9 score on a scale
Standard Deviation 16.5
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Product Was Pleasant
|
55.5 score on a scale
Standard Deviation 41.3
|
44.2 score on a scale
Standard Deviation 43.8
|
50.7 score on a scale
Standard Deviation 37.2
|
49.4 score on a scale
Standard Deviation 39.2
|
48.2 score on a scale
Standard Deviation 36.5
|
48.0 score on a scale
Standard Deviation 43.
|
40.6 score on a scale
Standard Deviation 37.6
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Reduce My Hunger
|
17.2 score on a scale
Standard Deviation 30.9
|
11.7 score on a scale
Standard Deviation 26.8
|
12.9 score on a scale
Standard Deviation 25.9
|
8.5 score on a scale
Standard Deviation 33.8
|
14.4 score on a scale
Standard Deviation 38.8
|
17.5 score on a scale
Standard Deviation 30.9
|
8.5 score on a scale
Standard Deviation 22.8
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Want Another One of Product
|
33.5 score on a scale
Standard Deviation 47.8
|
25.5 score on a scale
Standard Deviation 41.6
|
33.7 score on a scale
Standard Deviation 44.4
|
20.2 score on a scale
Standard Deviation 34.4
|
28.8 score on a scale
Standard Deviation 42.0
|
32.1 score on a scale
Standard Deviation 47.1
|
32.4 score on a scale
Standard Deviation 45.6
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Product was Satisfying
|
58.1 score on a scale
Standard Deviation 42.5
|
45.5 score on a scale
Standard Deviation 42.9
|
47.8 score on a scale
Standard Deviation 42.9
|
52.3 score on a scale
Standard Deviation 41.0
|
50.0 score on a scale
Standard Deviation 39.2
|
53.1 score on a scale
Standard Deviation 45.9
|
46.8 score on a scale
Standard Deviation 40.0
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Make Me Feel Sick
|
5.4 score on a scale
Standard Deviation 14.1
|
3.7 score on a scale
Standard Deviation 9.3
|
5.0 score on a scale
Standard Deviation 12.7
|
11.3 score on a scale
Standard Deviation 21.6
|
4.6 score on a scale
Standard Deviation 27.4
|
1.8 score on a scale
Standard Deviation 9.0
|
1.2 score on a scale
Standard Deviation 4.9
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Product Tastes Good
|
54.9 score on a scale
Standard Deviation 38.2
|
40.3 score on a scale
Standard Deviation 46.6
|
47.3 score on a scale
Standard Deviation 41.3
|
43.5 score on a scale
Standard Deviation 41.6
|
46.4 score on a scale
Standard Deviation 29.6
|
47.2 score on a scale
Standard Deviation 46.2
|
35.0 score on a scale
Standard Deviation 37.1
|
SECONDARY outcome
Timeframe: Up to 6.5 hoursThe DEQ will assess subjective ratings for "feel drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "feel drug effect". Higher scores indicates stronger (better) effects. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Perceived Strength of Effects as Assessed by the Drug Effect Questionnaire
|
33.7 score on a scale
Standard Deviation 38.1
|
44.4 score on a scale
Standard Deviation 37.9
|
23.4 score on a scale
Standard Deviation 28.2
|
39.2 score on a scale
Standard Deviation 39.2
|
37.0 score on a scale
Standard Deviation 36.8
|
45.7 score on a scale
Standard Deviation 37.5
|
37.0 score on a scale
Standard Deviation 40.1
|
SECONDARY outcome
Timeframe: Up to 6.5 hoursThe DEQ will assess subjective ratings for "dislike drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating a stronger (worse) perception of aversive or unpleasant drug effects. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Outcome measures
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 Participants
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 Participants
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Negative and Aversive Effects as Assessed by the Drug Effect Questionnaire
|
3.1 score on a scale
Standard Deviation 9.9
|
10.4 score on a scale
Standard Deviation 17.3
|
8.4 score on a scale
Standard Deviation 18.0
|
6.9 score on a scale
Standard Deviation 16.3
|
1.6 score on a scale
Standard Deviation 3.6
|
14.0 score on a scale
Standard Deviation 26.9
|
3.7 score on a scale
Standard Deviation 11.0
|
Adverse Events
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Original/Tobacco Flavored Pouch (High Nicotine Dose)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mint/Menthol Flavored Pouch (High Nicotine Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fruit Flavored Pouch (Low Nicotine Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fruit Flavored Pouch (High Nicotine Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Own Brand Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Original/Tobacco Flavored Pouch (Low Nicotine Dose)
n=28 participants at risk
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Original/Tobacco Flavored Pouch (High Nicotine Dose)
n=28 participants at risk
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (Low Nicotine Dose)
n=28 participants at risk
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Mint/Menthol Flavored Pouch (High Nicotine Dose)
n=28 participants at risk
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (Low Nicotine Dose)
n=28 participants at risk
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Fruit Flavored Pouch (High Nicotine Dose)
n=28 participants at risk
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
Nicotine: Nicotine pouches will be self-administered
|
Own Brand Cigarettes
n=28 participants at risk
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions
Cigarette: Cigarette will be smoked
|
|---|---|---|---|---|---|---|---|
|
Vascular disorders
Elevated Heart Rate/Blood Pressure
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
7.1%
2/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/28 • Up to 6.5 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
Additional Information
Dr. Tory Spindle
Johns Hopkins University School of Medicine
Phone: 4105500529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place