Effects of Nicotine Salt Aerosol on Cigarette Smokers

Not Applicable

Terminated

Conditions: Electronic Cigarette Use

Interventions: 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

Registration Number: NCT03974152

Lead Sponsor: Eastern Virginia Medical School

Brief 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette	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.
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine	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.
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine	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.
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine	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.
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette	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.
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine	Subox Mini C with Avail 18 mg nicotine salt (protonated)	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.
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine	Subox Mini C with Avail 18 mg nicotine (unprotonated)	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.
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine	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.

Primary Outcome Measures

Name	Time	Method
Plasma Nicotine	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.	Change in plasma nicotine level

Secondary Outcome Measures