Tobacco DependenceTENNCT05836051
Testing the Effect of ENDS Flavors on Neurotransmission
A study testing Flavor in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Flavor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 21 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
Who cannot join
- 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
Show all 11Show fewer
- 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-specific exclusion criteria:
- MRI safety contraindications (e.g., metal implants, claustrophobia)
- Major neurological conditions or brain trauma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive 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.
- Conditions
- Tobacco Dependence
- Being tested
- Flavor
- Keywords
- Tobacco, Nicotine, Smoking, Addiction
- Medical subject headings
- Tobacco Use Disorder, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavorOther
E-liquid flavor chemicals
| Study group | Role | What they receive |
|---|---|---|
| Hexyl Acetate | Experimental | E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt. Receives: Other: Flavor |
| Ethyl Acetate | Active comparator | E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt. Receives: Other: Flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre to post-intervention (approximately 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jun 2023
- Primary completion30 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Andrea Hobkirk, PhD, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836051
- Sponsor's protocol ID
- 19883; 24844
- Other IDs
- R61DA056764
- Acronym
- TEN
- Status last verified
- May 2026
- First submitted
- 18 Apr 2023
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of ENDS Flavors on Neurotransmission
- ClinicalTrials.gov ID
- NCT05836051
- Acronym / sponsor ID
- TEN / 19883; 24844
- Conditions
- Tobacco Dependence
- Keywords
- Tobacco, Nicotine, Smoking, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 flavor (hexyl acetate) vs. an inactive 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hexyl Acetate | Experimental | Other: FlavorE-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt. |
| Ethyl Acetate | Active comparator | Other: FlavorE-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlavorE-liquid flavor chemicals | Other | Ethyl Acetate, Hexyl Acetate |
Primary outcome
Brain Reward Reactivity
Time frame: Pre to post-intervention (approximately 10 days)
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.
Absolute Reinforcement
Time frame: Pre to post-intervention (approximately 10 days)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavor in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Reward Reactivity (time frame: Pre to post-intervention (approximately 10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.