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

NCT03830892 | Terminated Results

• 2 other identifiers: HM200126962U54DA036105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Subjective Measures of Nicotine Abstinence Symptoms

  First measure given, regardless of task order, 90 minutes into each session

• Subjective Measures of Nicotine Abstinence Symptoms

  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

  Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).

Study Arms (2)

E-cigarette User (Exclusive)

ACTIVE COMPARATOR

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; 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

Dual User

ACTIVE COMPARATOR

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; 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

Interventions

E-cigarette Lab Session 15 watts, 10 mg nicotine OTHER

E-cigarette paired with low nicotine, low device power

Dual User; E-cigarette User (Exclusive)

E-cigarette Lab Session 15 watts, 30 mg nicotine OTHER

E-cigarette paired with low nicotine, low device power

Dual User; E-cigarette User (Exclusive)

E-cigarette Lab Session 30 watts, 10 mg nicotine OTHER

E-cigarette paired with low nicotine, low device power

Dual User; E-cigarette User (Exclusive)

E-cigarette Lab Session 30 watts, 30 mg nicotine OTHER

E-cigarette paired with low nicotine, low device power

Dual User; E-cigarette User (Exclusive)

Own Brand Session - E-cigarette OTHER

E-cigarette paired with own brand liquid and preferred power

Dual User; E-cigarette User (Exclusive)

Own Brand Session - E-cigarette/Cigarette OTHER

Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power

Dual User

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for the Study of Tobacco Products

Richmond, Virginia, 23220, United States

Location

Related Publications (2)

• White AM, Bono RS, Lester RC, Underwood M, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. The electronic nicotine delivery system (ENDS) purchase task: Are results sensitive to price framing? Exp Clin Psychopharmacol. 2023 Oct;31(5):895-901. doi: 10.1037/pha0000631. Epub 2022 Dec 8.

  PMID: 36480388 DERIVED

• 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.

  PMID: 34647773 DERIVED

MeSH Terms

Conditions

Vaping

Interventions

Nicotine; Tobacco Products

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Andrew J. Barnes
• Organization: Virginia Commonwealth University

abarnes3@vcu.edu

804-827-4361

Study Officials

• Caroline Cobb (Amey), PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Andrew Barnes, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 5, 2019
• Study Start: January 18, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Locations

US (1)