Assessment of Two New Electronic Cigarettes in Cigarette Smokers

NCT03435562 | Completed Results

• 1 other identifier: HM20012013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Nicotine

  Change in plasma nicotine level

  Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

Secondary Outcomes (24)

• Carbon Monoxide Levels

  Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

• Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1

  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.

• Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2

  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.

• Hughes-Hatsukami Questionnaire - Anxious

  Questionnaire will be administered 4 times in 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.

• Hughes-Hatsukami Questionnaire - Craving

  Questionnaire will be administered 4 times in 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.

Other Outcomes (2)

• Heart Rate

  Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session

• Blood Pressure

  Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session

Study Arms (1)

electronic cigarette vs own brand use

EXPERIMENTAL

Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis.

Other: JUUL electronic cigarette; Other: IQOS electronic cigarette; Other: Own Brand cigarette

Interventions

JUUL electronic cigarette OTHER

Effects of JUUL electronic cigarette use.

electronic cigarette vs own brand use

IQOS electronic cigarette OTHER

Effects of IQOS electronic cigarette use.

electronic cigarette vs own brand use

Own Brand cigarette OTHER

Effects of own brand cigarette use.

electronic cigarette vs own brand use

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• cigarette smokers

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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Clinical Behavioral Pharmacolgy Laboratory

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: 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
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 19, 2018
• Study Start: March 3, 2018
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)