Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

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

Study Overview

• Status: Terminated
• Conditions: Electronic Cigarettes
• Intervention / Treatment: Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; Other: Own Brand Session - E-cigarette; Other: Own Brand Session - E-cigarette/Cigarette

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Center for the Study of Tobacco Products

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E-cigarette User (Exclusive); Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: Own Brand Session - E-cigarette; E-cigarette paired with own brand liquid and preferred power
Active Comparator: Dual User; Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; E-cigarette paired with low nicotine, low device power; Other: Own Brand Session - E-cigarette; E-cigarette paired with own brand liquid and preferred power; Other: Own Brand Session - E-cigarette/Cigarette; Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breakpoint of Drug Purchase Tasks (DPT)	The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes
Breakpoint of Multiple Choice Procedure (MCP)	The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes.
Effort for Product Puffs With the Progressive Ratio Task (PRT)	The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).	Up to 180 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	First measure given, regardless of task order, 90 minutes into each session
Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Subjective Measures of Nicotine Abstinence Symptoms	Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.	Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Change in Heart Rate	Heart rate (measured in bpm)	Recorded throughout each 4 hour study session using automated software every 10 seconds.
Change in Systolic Blood Pressure	Blood pressure (measured in mm)	Recorded throughout each 4 hour study session using automated software every 5 minutes.
Change in Diastolic Blood Pressure	and blood pressure (measured in hg)	Recorded throughout each 4 hour study session using automated software every 5 minutes.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: HM20012696; 2U54DA036105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No