Effects of Nicotine Salt Aerosol on Cigarette Smokers

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2020-03-05

Brief Summary

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This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

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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.

Conditions

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Electronic Cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine

In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.

Group Type EXPERIMENTAL

Subox Mini C with Avail 18 mg nicotine salt (protonated)

Intervention Type OTHER

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.

Subox Mini C with Avail 18 mg nicotine (unprotonated)

Intervention Type OTHER

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.

Own brand cigarette

Intervention Type OTHER

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.

Interventions

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Subox Mini C with Avail 18 mg nicotine salt (protonated)

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.

Intervention Type OTHER

Subox Mini C with Avail 18 mg nicotine (unprotonated)

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.

Intervention Type OTHER

Own brand cigarette

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.

Intervention Type OTHER

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes