Effects of Nicotine Salt Aerosol on Cigarette Smokers

Study Overview
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Brief Summary
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This grant compares the effects of cigarette smoking, protonated nicotine (salt) aerosol, and unprotonated nicotine aerosol on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

Detailed Description
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The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine salt (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.

Official Title
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Effects of Nicotine Salt Aerosol on Cigarette Smokers

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Other: Subox Mini C with Avail 18 mg nicotine salt (protonated)
* Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)
* Other: Own brand cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be: healthy (determined by self-report) between 21-55 years old wiling to provide informed consent able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol cigarette smokers Exclusion Criteria: • Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Own brand cigarette<br>Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. | Other: Own brand cigarette<br>* Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.<br>|
| Experimental: ENDS: Subox Mini C with 18 mg nicotine salt (protonated)<br>Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. | Other: Subox Mini C with Avail 18 mg nicotine salt (protonated)<br>* Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.<br>|
| Experimental: ENDS: Subox Mini C with 18 mg nicotine regular (unprotonated)<br>Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. | Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)<br>* Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Nicotine | Change in plasma nicotine level | Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. |