Health TrialsbyHealthPanel

Manipulating E-Cigarette Nicotine to Promote Public Health

ConditionTobacco-Related Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorOhio State University Comprehensive Cancer Center

About this trial

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no/minimal history of smoking cigarettes (≤ 10 cigarettes in entire life)

Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC

Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours for Study 1 and 2 hours for Study 2 before study visits

Read, write, and speak English

Disqualifiers

Currently attempting to quit nicotine or tobacco products

Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding

If age 21-24 years old AND use of any tobacco products other than ECs (use of >10 cigarettes in entire life; 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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Carbon Monoxide Measurement

    Procedure/Surgery

    Undergo CO test

  • Vaping session

    Other intervention

    Sample study e-liquids in vaping sessions at research lab with e-cig study device

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

375 Participants
are divided into 28 treatment groups

28

Treatment groups

See each treatment group below.

Group A: Phase 1, Arm 1 (High, Nic, S)Experimental treatment 4 interventions
Group B: Phase 1, Arm 2 (High, Nic, R/S)Experimental treatment 4 interventions
Group C: Phase 1, Arm 3 (Low, Nic, S)Experimental treatment 4 interventions
Group D: Phase 1, Arm 4 (Low, Nic, R/S)Experimental treatment 4 interventions
Group E: Phase 1, Arm 5 (High, NicH+, S)Experimental treatment 4 interventions
Group F: Phase 1, Arm 6 (High, NicH+, R/S)Experimental treatment 4 interventions
Group G: Phase 1, Arm 7 (Low, NicH+, S)Experimental treatment 4 interventions
Group H: Phase 1, Arm 8 (Low, NicH+, R/S)Experimental treatment 4 interventions
Group I: Phase 2, Arm 1 (High, 5%, S)Experimental treatment 4 interventions
Group J: Phase 2, Arm 2 (High, 5%, R/S)Experimental treatment 4 interventions
Group K: Phase 2, Arm 3 (Low, 5%, S)Experimental treatment 4 interventions
Group L: Phase 2, Arm 4 (Low, 5%, R/S)Experimental treatment 4 interventions
Group M: Phase 2, Arm 5 (High, 25%, S)Experimental treatment 4 interventions
Group N: Phase 2, Arm 6 (High, 25%, R/S)Experimental treatment 4 interventions
Group O: Phase 2, Arm 7 (Low, 25%, S)Experimental treatment 4 interventions
Group P: Phase 2, Arm 8 (Low, 25%, R/S)Experimental treatment 4 interventions
Group Q: Phase 2, Arm 9 (High, 45%, S)Experimental treatment 4 interventions
Group R: Phase 2, Arm 10 (High, 45%, R/S)Experimental treatment 4 interventions
Group S: Phase 2, Arm 11 (Low, 45%, S)Experimental treatment 4 interventions
Group T: Phase 2, Arm 12 (Low, 45%, R/S)Experimental treatment 4 interventions
Group U: Phase 2, Arm 13 (High , 65%, S)Experimental treatment 4 interventions
Group V: Phase 2, Arm 14 (High , 65%, R/S)Experimental treatment 4 interventions
Group W: Phase 2, Arm 15 (Low, 65%, S)Experimental treatment 4 interventions
Group X: Phase 2, Arm 16 (Low, 65%, R/S)Experimental treatment 4 interventions
Group Y: Phase 2, Arm 17 (High, 85%, S)Experimental treatment 4 interventions
Group Z: Phase 2, Arm 18 (High, 85%, R/S)Experimental treatment 4 interventions
Group [: Phase 2, Arm 19 (Low, 85%, S)Experimental treatment 4 interventions
Group \: Phase 2, Arm 20 (Low, 85%, R/S)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1)

Blood nicotine samples will be assayed using liquid chromatography tandem mass spectrometry (LC-MS/MS) with deuterated internal standards.

Time frame
Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
2

Nicotine pharmacokinetics: Time to maximum blood level (Tmax) (Study 1)

Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.

Time frame
Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
3

Nicotine pharmacokinetics: Area under the curve (AUC) (Study 1)

Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.

Time frame
Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
4

Nicotine metabolism (Study 1)

The rate of nicotine metabolism will be assessed using the standard method of nicotine metabolite ration (NMR) = hydroxycotinine/cotinine, modified to reflect stereoselective metabolism. Plasma concentration of cotinine, and hydroxycotinine will be measured by chiral LC-MS/MS based on previous methods and quantified using the ratio of metabolites to internal standards.

Time frame
At 60 minutes after the start of each puffing session

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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