Effects of Nicotine Salt Aerosol on Cigarette Smokers

Eastern Virginia Medical School (EVMS)

Status: Terminated

Conditions: Electronic Cigarette Use

Treatments: Other: Subox Mini C with Avail 18 mg nicotine (unprotonated); Other: Subox Mini C with Avail 18 mg nicotine salt (protonated); Other: Own brand cigarette

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03974152

19-01-FB-0009

FP00006477_SA007 (Other Grant/Funding Number)

U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

11 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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

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

Experimental group

Description:

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.

Treatment:

Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)

Other: Own brand cigarette

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