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E-Cigarette Flavors for Tobacco Addiction (TEN Trial)
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre to post-intervention (approximately 10 days)
Awards & highlights
TEN Trial Summary
This trial aims to see if chemicals in e-cigarettes can make them more addictive.
Who is the study for?
This trial is for adults over 21 who regularly use tobacco products like vapes, cigarettes, or cigars and have done so for the last three months. Participants should not be planning to quit tobacco within the next month and must be able to read and write in English.Check my eligibility
What is being tested?
The study is looking at how different flavors added to electronic nicotine delivery systems (ENDS) might change brain function and behavior, potentially affecting addiction levels.See study design
What are the potential side effects?
Since this trial focuses on flavor effects rather than a new medication, specific side effects are not listed. However, general risks associated with using ENDS may apply.
TEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre to post-intervention (approximately 10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre to post-intervention (approximately 10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute reinforcement
Brain reward reactivity
TEN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hexyl AcetateExperimental Treatment1 Intervention
E-cigarette liquid containing hexyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Group II: Ethyl AcetateActive Control1 Intervention
E-cigarette liquid containing ethyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
495 Previous Clinical Trials
2,798,824 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,681 Total Patients Enrolled
1 Trials studying Tobacco Addiction
450 Patients Enrolled for Tobacco Addiction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.I do not have any severe or uncontrolled health conditions.I am currently using medication to help me stop smoking.I have a significant brain condition or have had serious head injury.I have been using inhaled tobacco products weekly for the last three months.
Research Study Groups:
This trial has the following groups:- Group 1: Hexyl Acetate
- Group 2: Ethyl Acetate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being added to this research project?
"Clinicaltrials.gov reveals that this clinical trial has concluded recruitment and is not currently seeking participants. The posting was originally created on June 1st, 2023 and the last update occured on April 18th, 2023; however, 111 other trials have ongoing patient enrollment at present."
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