NCT02520349

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Truth Initiative · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DEVICE	MarkTen and e-Go e-cigarettes

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2015-08-11
• Last updated: 2020-10-06

Locations

2 sites across 1 country: United States