Effects of Nicotine Salt Aerosol on Cigarette Smokers

NCT03974152 | Terminated Results

• 3 other identifiers: 19-01-FB-0009U54DA036105FP00006477_SA007
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (6)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

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

Subox Mini C with Avail 18 mg nicotine (unprotonated) 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.

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

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

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Paul Harrell
• Organization: Eastern Virginia Medical School

harrelpt@evms.edu

757-446-6047

Study Officials

• Paul T Harrell, Ph.D.

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: June 10, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: March 26, 2024
• Results First Posted: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)