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

NCT02520349 | Completed DMC

• 1 other identifier: 5K01DA037950
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

MarkTen and e-Go e-cigarettes DEVICE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• be between 18-65 years of age;
• reside in the Richmond metro area;
• be proficient in English;
• be interested in trying e-cigarettes, assessed at the initial screening;
• have no immediate plans (in the next 30 days) to quit smoking;
• have an active email address (for online follow-up surveys);
• 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.

You may not qualify if:

• Individuals fitting any of the following criteria will not be eligible to participate.
• Individuals who have used e-cigarettes in the past 30 days;
• Individuals who used e-cigarettes more than 5 times in their lives;
• Individuals with uncontrolled or unstable medical or psychiatric conditions;
• Individuals with current or recent (within 6 months) drug/alcohol abuse;
• Individuals who weigh less than 110 lbs;
• 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 \[over 90 BPM\]);
• Women who are currently pregnant/breastfeeding or who have plans to become pregnant.

Sponsors & Collaborators

• Truth Initiative: lead
• Virginia Commonwealth University: collaborator

Study Sites (2)

American Legacy Foundation

Washington D.C., District of Columbia, 20001, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma nicotine: Investigators will examine change in plasma nicotine concentration before and after 5 minutes of directed product use (10 total puffs). At the start of the session, a phlebotomist will draw 7mL of blood via venipuncture (no catheter). Participants will then be directed to take a puff of their own brand/assigned e-cigarette device every 30 seconds for 5 minutes. At the end of the directed use session, the phlebotomist will draw another 7mL of blood via venipuncture. Blood samples will be processed at the Center for Study of Tobacco Products lab, frozen, and walked across the street to the Bioanalytical Mass Spectrometry Core Laboratory at VCU for cotinine/3-OH analysis using previously developed assays. Blood samples will not be retained for additional analyses.

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jennifer Pearson, PhD

  Truth Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 11, 2015
• Study Start: May 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)