Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

NCT04332926 | Completed Results

• 2 other identifiers: HM200182902U54DA036105
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.

Conditions

Electronic Cigarette Use

Keywords

Electronic Cigarette; Nicotine Flux

Outcome Measures

Primary Outcomes (3)

• Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)

  This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.

  The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.

• Breakpoint of Drug Purchase Task (DPT)

  The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.

  Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).

• Effort for Product Puffs With 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) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.

  The PRT is completed once per study session, at 85 minutes into the session.

Study Arms (1)

Experimental

EXPERIMENTAL

Other: Tobacco product administration and assessment, own brand cigarettes; Other: Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine

Interventions

Tobacco product administration and assessment, own brand cigarettes OTHER

4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Experimental

Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine OTHER

4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Experimental

Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine OTHER

4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Experimental

Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine OTHER

4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Experimental

Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine OTHER

4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Experimental

Eligibility Criteria

• Age: 18 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 18-55
• 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

MeSH Terms

Conditions

Vaping

Interventions

Restraint, Physical; Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Caroline Cobb, PhD, PI
• Organization: Virginia Commonwealth University

cobbco@vcu.edu

804-828-8687

Study Officials

• Caroline O Cobb, 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: NA
• Masking: NONE
• Masking Details: Participants will be blinded to their condition (nicotine level) used in each session, except during their 'own brand' session.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 3, 2020
• Study Start: January 5, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 8, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)