Lab to Real World Assessment of E-cigarette Abuse Liability and Appeal

The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An additional aim is to evaluate e-cigarette safety and tolerability among smokers by device type.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Device: MarkTen and e-Go e-cigarettes

Detailed Description

The proposed research is a longitudinal human lab study to involving 6 lab visits and 3 follow-up surveys at 1, 3, and 6 months after participants' last lab visit. Investigators will enroll 30 smokers (≥10 cig/day) who have not used e-cigarettes in the past 30 days and have never used e-cigarettes "fairly regularly." After a telephone screening to confirm eligibility, participants will attend Virginia Commonwealth University's (VCU) Clinical Behavioral Pharmacology Laboratory for all lab visits. The specific aims are to:

Aim 1. Examine how measures of abuse liability and product appeal vary by ECIG device type (Markten vs. e-Go).

Aim 2. Compare differences in abuse liability and product appeal between participants' usual brand of tobacco cigarette, Markten, and e-Go.

Aim 3. As an exploratory aim, examine the extent to which measures of abuse liability and product appeal as measured in the lab (including TPPT) predict participants' real-world ECIG use at the 1-, 3-, and 6-month follow-up surveys.

Aim 4. To monitor safety and tolerability the MarkTen and e-Go among smokers.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20001
      • American Legacy Foundation
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 30 community volunteers who currently use 10 or more cigarettes per day and have no immediate plans to quit smoking will be enrolled. Investigators will attempt to recruit an equal number of men and women of diverse racial/ethnic backgrounds. This preliminary study is not intended to address gender or race/ethnic differences.

Description

Inclusion Criteria:

1. be between 18-65 years of age;
2. reside in the Richmond metro area;
3. be proficient in English;
4. be interested in trying e-cigarettes, assessed at the initial screening;
5. have no immediate plans (in the next 30 days) to quit smoking;
6. have an active email address (for online follow-up surveys);
7. report current cigarette use (≥10 CPD for ≥1 year). To biochemically confirm cigarette smoking status, eligible participants must have an exhaled carbon monoxide (CO) of ≥15ppm at screening using a Vitalograph CO monitor.

Exclusion Criteria:

Individuals fitting any of the following criteria will not be eligible to participate.

1. Individuals who have used e-cigarettes in the past 30 days;
2. Individuals who used e-cigarettes more than 5 times in their lives;
3. Individuals with uncontrolled or unstable medical or psychiatric conditions;
4. Individuals with current or recent (within 6 months) drug/alcohol abuse;
5. Individuals who weigh less than 110 lbs;
6. Individuals with conditions that would require medical attention during the course of the study (such as hypertension [systolic BP over 140, diastolic BP over 90] or elevated heart rate [over 90 BPM]);
7. Women who are currently pregnant/breastfeeding or who have plans to become pregnant.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood nicotine concentration	A phlebotomist will draw 7mL of blood via venipuncture (no catheter) before and after directed tobacco product use at Lab Visits 2-6.	3 weeks - before and after product administration
Nicotine withdrawal symptom alleviation	Participants will answer questions about their nicotine withdrawal symptoms (e.g. headache, tired, etc)	3 weeks - before and after product administration
Change in subjective tobacco product appeal	Participants will answer questions about the positive and negative physical effects of using the product and how much they like the product.	3 weeks - before and after product administration
Change in heart rate	Participants' heart rate (HR) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish a resting HR.	3 weeks - before and after product administration
Number of Participants with Adverse Events by ECIG Device Type as a Measure of Safety and Tolerability	A count of the number of participants who report adverse events associated with the study, such as headache, chest pain, cough/sputum, nausea/vomiting, dizziness, confusion/stupor, feeling sick, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and tiredness, by e-cigarette device type.	3 weeks - before and after product administration
Change in blood pressure	Participants' blood pressure (BP) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish resting BP.	3 weeks - before and after product administration

Collaborators and Investigators

• Sponsor: Truth Initiative
• Collaborators: Virginia Commonwealth University
• Investigators: Principal Investigator: Jennifer Pearson, PhD, Truth Initiative

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 5K01DA037950 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes