Clinical trial NCT03830892: Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Official title: Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Electronic Cigarettes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes.

All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette.

The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.


Eligibility criteria: Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 21-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Primary outcomes:
measure: Breakpoint of Drug Purchase Tasks (DPT)
timeFrame: Up to 180 minutes
measure: Breakpoint of Multiple Choice Procedure (MCP)
timeFrame: Up to 180 minutes.
measure: Effort for Product Puffs With the Progressive Ratio Task (PRT)
timeFrame: Up to 180 minutes.
Secondary outcomes:
Other outcomes:
measure: Subjective Measures of Nicotine Abstinence Symptoms
timeFrame: First measure given, regardless of task order, 90 minutes into each session
measure: Subjective Measures of Nicotine Abstinence Symptoms
timeFrame: Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
measure: Subjective Measures of Nicotine Abstinence Symptoms
timeFrame: Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
measure: Subjective Measures of Nicotine Abstinence Symptoms
timeFrame: Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
measure: Change in Heart Rate
timeFrame: Recorded throughout each 4 hour study session using automated software every 10 seconds.
measure: Change in Systolic Blood Pressure
timeFrame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
measure: Change in Diastolic Blood Pressure
timeFrame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
Locations:
city: Richmond
country: United States
facility: Center for the Study of Tobacco Products
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Caroline Cobb (Amey), PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Andrew Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoetger C, Bono RS, White AM, Barnes AJ, Cobb CO. The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes. Exp Clin Psychopharmacol. 2022 Dec;30(6):973-982. doi: 10.1037/pha0000523. Epub 2021 Oct 14.