NCT05836051

Brief Summary

The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 18, 2023

Results QC Date

May 28, 2026

Last Update Submit

August 5, 2026

Conditions

Tobacco Dependence

Keywords

TobaccoNicotineSmokingAddiction

Outcome Measures

Primary Outcomes (2)

  • Brain Reward Reactivity

    Brain reward reactivity will be calculated as the difference in the percent of BOLD signal calculated by subtracting the absolute percentage at the post-scan from baseline in a pre-defined ventral tegmental area (VTA) region of interest during electronic nicotine delivery system (ENDS) inhalation.

    Pre to post-intervention (approximately 10 days)

  • Absolute Reinforcement

    Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period.

    Pre to post-intervention (approximately 10 days)

Study Arms (2)

Hexyl Acetate

EXPERIMENTAL

E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.

Other: Flavor

Ethyl Acetate

ACTIVE COMPARATOR

E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.

Other: Flavor

Interventions

FlavorOTHER

E-liquid flavor chemicals

Ethyl AcetateHexyl Acetate

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 years old
  • Regular users of inhaled tobacco products (≥5 days out of the last 28)
  • Not planning to quit tobacco use within next month
  • Able to read and write in English

You may not qualify if:

  • Major neurological conditions or brain trauma
  • Current substance use impairing participation
  • Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
  • Current use of smoking cessation medication (e.g., varenicline, patch)
  • Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
  • Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
  • Unable to use study provided ENDS ad-libitum for at least 3 hours per day
  • Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen
  • MRI safety contraindications (e.g., metal implants, claustrophobia)
  • Major neurological conditions or brain trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmokingBehavior, Addictive

Interventions

Flavoring Agents

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Andrea Hobkirk
Organization
Penn State College of Medicine
alh98@psu.edu
717-531-7279

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 1, 2023

Study Start

June 1, 2023

Primary Completion

May 30, 2025

Study Completion

July 31, 2025

Last Updated

August 7, 2026

Results First Posted

August 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

We do not have explicit plans to share IPD on open-access or publicly accessible repositories. However, IPD will be de-identified and formatted along with codebooks to facilitate data sharing with investigators upon request and after the completion of a Data Use Agreement.

Locations

US(1)