Back to resultsTesting the Effect of ENDS Flavors on Neurotransmission (TEN)
Primary Purpose
Tobacco Dependence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flavor
Sponsored by
About this trial
This is an interventional health services research trial for Tobacco Dependence focused on measuring Tobacco, Nicotine, Smoking, Addiction
Eligibility Criteria
Inclusion Criteria: 21 years old or older Weekly user of inhaled tobacco products, including inhaled ENDS, nicotine vapes, cigarettes, regular and little cigars for at least last three months Not planning to quit tobacco use within next month Able to read and write in English Exclusion Criteria: 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 Unable or unwilling to abstain from nicotine products for 14 hours prior to the scheduled visit, self-reported. MRI-specific exclusion criteria: MRI safety contraindications (e.g., metal implants, claustrophobia) Major neurological conditions or brain trauma
Sites / Locations
- Penn State HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hexyl Acetate
Ethyl Acetate
Arm Description
E-cigarette liquid containing hexyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
E-cigarette liquid containing ethyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Outcomes
Primary Outcome Measures
Brain reward reactivity
Brain reward reactivity will be calculated as the percent change in average blood oxygen-level dependent (BOLD) signal in a pre-defined ventral tegmental area (VTA) region of interest during ENDS inhalation
Absolute reinforcement
Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period
Secondary Outcome Measures
Full Information
NCT ID
NCT05836051
First Posted
April 18, 2023
Last Updated
July 7, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05836051
Brief Title
Testing the Effect of ENDS Flavors on Neurotransmission
Acronym
TEN
Official Title
Testing the Effect of ENDS Flavors on Neurotransmission
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive green-apple flavor (hexyl acetate) vs. an inactive green-apple flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Tobacco, Nicotine, Smoking, Addiction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hexyl Acetate
Arm Type
Experimental
Arm Description
E-cigarette liquid containing hexyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Arm Title
Ethyl Acetate
Arm Type
Active Comparator
Arm Description
E-cigarette liquid containing ethyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Intervention Type
Other
Intervention Name(s)
Flavor
Intervention Description
E-liquid flavor chemicals
Primary Outcome Measure Information:
Title
Brain reward reactivity
Description
Brain reward reactivity will be calculated as the percent change in average blood oxygen-level dependent (BOLD) signal in a pre-defined ventral tegmental area (VTA) region of interest during ENDS inhalation
Time Frame
Pre to post-intervention (approximately 10 days)
Title
Absolute reinforcement
Description
Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period
Time Frame
Pre to post-intervention (approximately 10 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
21 years old or older
Weekly user of inhaled tobacco products, including inhaled ENDS, nicotine vapes, cigarettes, regular and little cigars for at least last three months
Not planning to quit tobacco use within next month
Able to read and write in English
Exclusion Criteria:
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
Unable or unwilling to abstain from nicotine products for 14 hours prior to the scheduled visit, self-reported.
MRI-specific exclusion criteria:
MRI safety contraindications (e.g., metal implants, claustrophobia)
Major neurological conditions or brain trauma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Hobkirk, PhD
Phone
717-531-0003
Ext
286415
Email
ahobkirk@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Houser, MS
Phone
717-531-5473
Email
khouser@pennstatehealth.psu.edu
Facility Information:
Facility Name
Penn State Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Houser, MS
Phone
717-531-5473
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Testing the Effect of ENDS Flavors on Neurotransmission
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