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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Device: MarkTen and e-Go e-cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MarkTen and e-Go e-cigarettes|nan|

What is the study measuring?
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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 |