Effects of Nicotine Salt Aerosol on Cigarette Smokers

Electronic Cigarette Use Clinical Trial

Official title:

Effects of Nicotine Salt Aerosol on Cigarette Smokers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03974152
• Other study ID #: 19-01-FB-0009
• Secondary ID: U54DA036105FP000
• Status: Terminated
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: February 2024
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.