Clinical Trials Directory

Trials / Terminated

TerminatedNCT03974152

Effects of Nicotine Salt Aerosol on Cigarette Smokers

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Eastern Virginia Medical School · Academic / Other
Sex
All
Age
21 Years – 55 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
OTHERSubox 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.
OTHERSubox 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.
OTHEROwn brand cigaretteParticipants 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.

Timeline

Start date
2019-06-10
Primary completion
2020-03-05
Completion
2020-03-05
First posted
2019-06-04
Last updated
2024-03-26
Results posted
2024-02-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03974152. Inclusion in this directory is not an endorsement.