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Nicotine Levels in E-Cigarettes for Tobacco-Related Cancer Prevention

N/A
Recruiting
Led By Theodore L Wagener
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 older than 18 years old
Must not have
Current daily use of other tobacco products other than ECs or cigarettes (use of > 10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products > 10 times in entire life; or hookah in the last 30 days)
Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

"This trial investigates how changing the nicotine levels in e-cigarettes can impact public health. Researchers are studying how different forms and strengths of nicotine in e-cigarettes can affect addiction and health risks. The goal is to

Who is the study for?
This trial is for individuals interested in the effects of e-cigarette nicotine on health. It's not specified who can't join, but typically participants should be healthy adults, possibly smokers or e-cigarette users.
What is being tested?
The study investigates how manipulating nicotine levels in e-cigarettes affects addiction potential and health risks. Participants will undergo vaping sessions, provide biospecimens, have their carbon monoxide levels measured, and complete surveys.
What are the potential side effects?
While specific side effects are not listed for this observational study, typical concerns with vaping include throat irritation, coughing, dry mouth or eyes, and potentially increased cancer risk.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not use tobacco products daily except for e-cigarettes or cigarettes.
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I have been diagnosed with a lung condition such as asthma, cystic fibrosis, or COPD.
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I am not taking drugs like rifampicin or phenobarbital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Effects/Liking Questionnaire (DEQ)(Study 1)
General Labeled Magnitude Scale (gLMS) (Study 2)
In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1)
+21 more

Trial Design

28Treatment groups
Experimental Treatment
Group I: Phase 2, Arm 9 (High, 45%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group II: Phase 2, Arm 8 (Low, 25%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group III: Phase 2, Arm 7 (Low, 25%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group IV: Phase 2, Arm 6 (High, 25%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group V: Phase 2, Arm 5 (High, 25%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group VI: Phase 2, Arm 4 (Low, 5%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group VII: Phase 2, Arm 3 (Low, 5%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group VIII: Phase 2, Arm 20 (Low, 85%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group IX: Phase 2, Arm 2 (High, 5%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group X: Phase 2, Arm 19 (Low, 85%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XI: Phase 2, Arm 18 (High, 85%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XII: Phase 2, Arm 17 (High, 85%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XIII: Phase 2, Arm 16 (Low, 65%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XIV: Phase 2, Arm 15 (Low, 65%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XV: Phase 2, Arm 14 (High , 65%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XVI: Phase 2, Arm 13 (High , 65%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XVII: Phase 2, Arm 12 (Low, 45%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XVIII: Phase 2, Arm 11 (Low, 45%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XIX: Phase 2, Arm 10 (High, 45%, R/S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XX: Phase 2, Arm 1 (High, 5%, S)Experimental Treatment4 Interventions
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during a single visit lasting up to 6 hours.
Group XXI: Phase 1, Arm 8 (Low, NicH+, R/S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXII: Phase 1, Arm 7 (Low, NicH+, S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXIII: Phase 1, Arm 6 (High, NicH+, R/S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXIV: Phase 1, Arm 5 (High, NicH+, S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXV: Phase 1, Arm 4 (Low, Nic, R/S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXVI: Phase 1, Arm 3 (Low, Nic, S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXVII: Phase 1, Arm 2 (High, Nic, R/S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Group XXVIII: Phase 1, Arm 1 (High, Nic, S)Experimental Treatment4 Interventions
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020

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Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
334 Previous Clinical Trials
291,258 Total Patients Enrolled
Theodore L WagenerPrincipal InvestigatorOhio State University Comprehensive Cancer Center
~233 spots leftby May 2027
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