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

NCT ID: NCT02520349

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-08-31

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.

Conditions

Nicotine Dependence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MarkTen and e-Go e-cigarettes

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Truth Initiative

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Pearson

Research Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Pearson, PhD

Role: PRINCIPAL_INVESTIGATOR

Truth Initiative

Locations

American Legacy Foundation

Washington D.C., District of Columbia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

5K01DA037950

Identifier Type: NIH

Identifier Source: org_study_id

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