E-Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users

December 16, 2020 updated by: University of Oklahoma

Investigation of Electronic Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users

The FDA has shown clear interest in strategies that will reduce the public health burden of tobacco use. One proposed strategy includes banning the sale of fully nicotinized cigarettes and only allowing VLNCs (Very Low Nicotine Cigarettes) to be sold. While there are concerns regarding the unintended consequences (e.g., black market sales of fully nicotinized cigarettes) of such bans, research is needed to understand how smokers and dual users will act in the potential market. The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if the proposed ban were to go into effect.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Tobacco use continues to be the leading cause of preventable death in the US, with the majority of deaths due to combustible tobacco use. Electronic cigarettes (e-cigarettes) may represent a nicotine delivery device that addresses cravings and nicotine withdrawal and is much less harmful compared to cigarettes, particularly if completely substituted for cigarettes. The Food and Drug Administration (FDA) recently set forth plans that include the possibility of regulating the level of nicotine in combustible cigarettes to make them non-addictive and disallowing the sale of fully nicotinized cigarettes. While studies have shown that lowering the level of nicotine in cigarettes leads to high quit rates and would likely have a positive overall public health impact, there are concerns that doing so will lead to a black market for purchasing fully nicotinized cigarettes. However, no empirical evidence currently exists regarding this possible unintended consequence of the proposed regulation and the current project aims to fill this gap. Current smokers and dual cigarette and e-cigarette users will complete three in-lab study visits. Following screening and practice with all study products, participants will complete standardized 10-puff bouts for three e-cigarettes, the VLNCs (Very Low Nicotine Cigarettes), and their usual brand cigarette. They will then complete three concurrent choice tasks. The tasks will simulate 1) the current market, in which e-cigarettes and fully nicotinized cigarettes are available, 2) the potential future market in which e-cigarettes and VLNC (Very Low Nicotine Cigarettes) are freely available and nicotinized cigarettes are banned, and 3) the potential future market in which only tobacco flavored e-cigarettes and VLNCs (Very Low Nicotine Cigarettes) are freely available and nicotinized cigarettes are banned. Understanding, in an environment where VLNCs (Very Low Nicotine Cigarettes) are the only cigarettes available, current smokers' and dual users' product choices will fill an important gap in the research and inform regulation of these products.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center Oklahoma Tobacco Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A sample of 40 current cigarette smokers (n=20) and dual e-cigarette and cigarette users (n=20) who are willing to use/try an alternative nicotine-delivery device will be recruited via advertisements/ recruitment materials (e.g., craigslist, ads on OSU, OU, and UCO campuses, OUHSC, email) and referrals. Participants will live in the Oklahoma City, OK metro area. Participants will be provided information about the study and provide initial consent for screening via an online screener.

Description

Inclusion Criteria:

  • be at least 18 years old
  • live within 30 miles of the research site
  • interested in/willing to use an e-cigarette during study visits
  • be willing and able to complete study procedures including specimen collection, survey completion, and remaining nicotine abstinent for 12 hours prior to each study visit
  • speak and understand English
  • willing to provide informed consent
  • bring usual brand cigarettes to screener study visit.

Additional Inclusion criteria for smokers:

  • smoke at least 10 cigarettes per day for the past three months,
  • exhaled more than equal to 6 ppm carbon monoxide at the screener visit.

Additional Inclusion criteria for dual users:

  • smoke more than equal to 5 tobacco cigarettes per day for the last 3 months,
  • use e-cigarettes at least 15 days per month for the last 3 months, and
  • bring e-cigarette device to screener study visit.

Exclusion Criteria:

  • currently suffering from lung disease including asthma, cystic fibrosis (CF), or chronic obstructive pulmonary disease (COPD), unless it is well-controlled,
  • currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study,
  • intoxicated at study visits (breath alcohol testing and clean urine drug screen),
  • any known allergies or sensitivity to the known major constituents contained in the aerosol of the study e-cigarette devices (e.g., flavorants, vegetable glycerin, propylene glycol),
  • User of zero-nicotine e-cigarettes,
  • smokes mentholated cigarettes regularly,
  • history of cardiac event or distress within the past 3 months.

Additional Exclusion criteria for smokers:

  • have previously used any e-cigarette device (cig-a-like, pen style, mod, APV) for longer than 30 days
  • use of an e-cigarette device over the past 14 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Exclusive cigarette smokers
Exclusive cigarette smokers must smoke at least 10 cigarettes per day for the past three months and have exhaled carbon monoxide (eCO) levels of at least 6 ppm at the screening visit.
Dual (Electronic cigarette and cigarette smoking) users
Dual e-cigarette and cigarette users must have smoked at least 5 cigarettes per day for the last 3 months and use e-cigarettes at least 15 days per month for the last 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nicotine delivery measured by serum (blood) nicotine
Time Frame: 1 month
Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes, usual brand cigarette and Very Low Nicotine Cigarettes (VLNCs). Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.
1 month
Proportion of puffs earned and allocated to each product in three hypothetical tobacco regulatory scenarios
Time Frame: 1 month
Participants will complete three computer tasks simulating hypothetical regulatory scenarios and will earn and allocate puffs to study products. A greater proportion of puffs allocated will indicate greater demand for the product in that hypothetical scenario
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Theodore Wagener, PhD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8841

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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