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

Completed

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT02520349

Run by

Truth Initiative

People needed

80

Starts

2016-05-01

Expected to finish

2018-08-31

Last updated by the study team

2020-10-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• American Legacy Foundation — Washington D.C., District of Columbia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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