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

Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - 65
Start Date:May 2016
End Date:August 31, 2018
Contact:Jennifer Pearson, PhD

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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

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.

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.
We found this trial at
Richmond, Virginia 23298
(804) 828-0100
Phone: 804-827-3562
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Richmond, VA
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Washington, District of Columbia 20036
Phone: 202-454-5768
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