NCT03710590

Brief Summary

The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 20, 2021

Completed
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

October 9, 2018

Results QC Date

February 9, 2021

Last Update Submit

September 29, 2022

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (3)

  • Change in Plasma Nicotine

    Change in plasma nicotine level.

    Baseline to 5 min after the start of a 10-puff product use

  • Puff Volume

    The average volume of each puff, in ml, during 10 puff bout.

    Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

  • Puff Duration

    The average duration of each puff, in seconds.

    Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

Secondary Outcomes (1)

  • Heart Rate

    Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes

Other Outcomes (8)

  • Inter Puff Interval

    Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

  • Flow Rate

    Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

  • Hughes-Hatsukami Questionnaire

    Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

  • +5 more other outcomes

Study Arms (2)

Cigarette smokers

ACTIVE COMPARATOR
Other: ECIG Lab Session 15 watts, 10 mg nicotineOther: ECIG Lab Session 15 watts, 15 mg nicotineOther: ECIG Lab Session 15 watts, 30 mg nicotineOther: ECIG Lab Session 30 watts, 10 mg nicotineOther: ECIG Lab Session 30 watts, 15 mg nicotineOther: ECIG Lab Session 30 watts, 30 mg nicotine

Electronic cigarette users

ACTIVE COMPARATOR
Other: ECIG Lab Session 15 watts, 10 mg nicotineOther: ECIG Lab Session 15 watts, 15 mg nicotineOther: ECIG Lab Session 15 watts, 30 mg nicotineOther: ECIG Lab Session 30 watts, 10 mg nicotineOther: ECIG Lab Session 30 watts, 15 mg nicotineOther: ECIG Lab Session 30 watts, 30 mg nicotine

Interventions

ECIG Lab Session 15 watts, 10 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette smokersElectronic cigarette users
ECIG Lab Session 15 watts, 15 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).

Cigarette smokersElectronic cigarette users
ECIG Lab Session 15 watts, 30 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette smokersElectronic cigarette users
ECIG Lab Session 30 watts, 10 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette smokersElectronic cigarette users
ECIG Lab Session 30 watts, 15 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette smokersElectronic cigarette users
ECIG Lab Session 30 watts, 30 mg nicotineOTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette smokersElectronic cigarette users

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy (determined by self-report)
  • between the ages of 18-55
  • willing to provide informed consent
  • able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

You may not qualify if:

  • Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
  • Individuals who weigh less than 110 pounds
  • Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Behavioral Pharmacolgy Laboratory

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13.

    PMID: 35696157DERIVED

MeSH Terms

Conditions

Vaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Alison Breland
Organization
Virginia Commonwealth University
abbrelan@vcu.edu
804 628 2300

Study Officials

  • Alison Breland, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the power level and nicotine concentration used in each session.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 18, 2018

Study Start

January 15, 2019

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

October 6, 2022

Results First Posted

May 20, 2021

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)