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

Completed

• Conditions: Nicotine Dependence

• Registration Number: NCT02520349
• Lead Sponsor: Truth Initiative

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.

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 Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Study Start: 2016-05
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in blood nicotine concentration	3 weeks - before and after product administration	A phlebotomist will draw 7mL of blood via venipuncture (no catheter) before and after directed tobacco product use at Lab Visits 2-6.
Nicotine withdrawal symptom alleviation	3 weeks - before and after product administration	Participants will answer questions about their nicotine withdrawal symptoms (e.g. headache, tired, etc)
Change in heart rate	3 weeks - before and after product administration	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.
Change in subjective tobacco product appeal	3 weeks - before and after product administration	Participants will answer questions about the positive and negative physical effects of using the product and how much they like the product.
Number of Participants with Adverse Events by ECIG Device Type as a Measure of Safety and Tolerability	3 weeks - before and after product administration	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.
Change in blood pressure	3 weeks - before and after product administration	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.

Trial Locations

Locations (2)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

American Legacy Foundation; 🇺🇸 Washington, District of Columbia, United States