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

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520349
• Other study ID #: 5K01DA037950
• Status: Completed
• Start date: May 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2020
• Source: Truth Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Device:
• MarkTen and e-Go e-cigarettes

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	American Legacy Foundation	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Truth Initiative	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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