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E-Cigarette Variations for Youth Vaping Behavior
N/A
Waitlist Available
Led By Marielle Brinkman, BS
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 5, 10, 35 min.
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how nicotine form, concentration, and flavor affects youth vaping behavior and health.
Who is the study for?
This trial is for young adults aged 21-25 who exclusively use e-cigarettes daily for the last 3 months. Participants must abstain from all tobacco and nicotine for 12 hours before lab sessions, commit to five lab visits, and not be pregnant or breastfeeding. Those with unstable psychiatric conditions, recent heart issues, frequent marijuana use, other tobacco product use, or lung diseases like asthma are excluded.
What is being tested?
The study investigates how different forms of nicotine in e-cigarettes (varying in concentration and flavor) affect vaping habits and health outcomes in youth. It involves multiple lab sessions where participants' responses to these variations are observed.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include throat irritation, coughing, dry mouth or throat; increased heart rate or blood pressure; headaches; dizziness; nausea; changes in taste perception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 5, 10, 35 min.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 5, 10, 35 min.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Airway Inflammation (NIOX VERO)
Average Puff Duration
Average Puff Volume
+3 moreSecondary study objectives
Drug Effects/Liking Questionnaire
E-cigarette Purchase Task - Breakpoint
Modified Cigarette Dependence Scale
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Low concentration nicotine salt (1%), Tobacco flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group II: Low concentration nicotine salt (1%), Menthol flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group III: Low concentration free-base nicotine (1%), Tobacco flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group IV: Low concentration free-base nicotine (1%), Menthol flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group V: High concentration nicotine salt (5%), Tobacco flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group VI: High concentration nicotine salt (5%), Menthol flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group VII: High concentration free-base nicotine (5%), Tobacco flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Group VIII: High concentration free-base nicotine (5%), Menthol flavorExperimental Treatment1 Intervention
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
293,119 Total Patients Enrolled
Marielle Brinkman, BSPrincipal InvestigatorOhio State University
Theodore L Wagener, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
2,002 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 25 years old.I am willing to attend five 6-hour lab visits.I have been exclusively using e-cigarettes daily for the last 3 months.I have been diagnosed with a lung disease such as asthma, cystic fibrosis, or COPD.I have not had a heart problem in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Low concentration free-base nicotine (1%), Tobacco flavor
- Group 2: High concentration free-base nicotine (5%), Tobacco flavor
- Group 3: High concentration nicotine salt (5%), Tobacco flavor
- Group 4: Low concentration nicotine salt (1%), Tobacco flavor
- Group 5: High concentration free-base nicotine (5%), Menthol flavor
- Group 6: High concentration nicotine salt (5%), Menthol flavor
- Group 7: Low concentration free-base nicotine (1%), Menthol flavor
- Group 8: Low concentration nicotine salt (1%), Menthol flavor
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.