Nicotine Dependence
Conditions
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.
Interventions
DEVICEMarkTen and e-Go e-cigarettes
Sponsors
Virginia Commonwealth University
Truth Initiative
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed