Comparing Electronic Cigarette User Preferences and Smoking Behaviors of Nicotine Analogs to Nicotine to Improve the Understanding of Nicotine Analog Addictiveness

This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults. Though progress has been made in regulating nicotine containing products, some companies have shifted toward producing products containing nicotine analogs. ECs are battery-powered electronic devices designed to atomize a nicotine (the poisonous chemical found in tobacco)-containing liquid solution for inhalation in a manner that simulates smoking a tobacco cigarette. When nicotine enters the body, it causes an increased heart rate and use of oxygen by the heart, and a sense of well-being and relaxation. Nicotine analogs are compounds that are similar to nicotine in their chemical structure. Some nicotine analogs have been shown to have nicotine-like effects; however, more research is needed to prove they function similarly to nicotine and/or have similar effects. Comparing EC user preferences and smoking behaviors of nicotine analogs to nicotine may help improve the understanding of nicotine analog addictiveness.

Inclusion Criteria

Aged 21 years or older
Current adult EC user for at least the past 3 months (confirmed by cotinine testing strip)
Willing and able to provide informed consent
Willing to abstain from using any nicotine, tobacco, or marijuana products for 12 or more hours prior to the three lab visits
Able to read, write, and speak English

Exclusion Criteria

Currently attempting to quit nicotine or tobacco products
Use of other tobacco or nicotine products > 10 days in the past month
Have had a recent cardiac event or distress (defined as occurring within the previous 3 months)
Have had a recent serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, asthma, or lung cancer) (defined as occurring in the previous 30 days)
Currently pregnant, planning to become pregnant, or breastfeeding (verified with urine pregnancy test)

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07585006.

United States

Ohio

Columbus

Ohio State University Comprehensive Cancer Center

Status: Active

Contact: Theodore L. Wagener

Phone: 844-744-2447

Email: Theodore.Wagener@osumc.edu

PRIMARY OBJECTIVES:

I. To assess the subjective effects and behavioral economic demand of 6-methyl nicotine (6-MN) and nicotinamide.

II. To assess the use topography of 6-MN and nicotinamide.

III. To conduct exploratory pharmacokinetics of 6-MN and nicotinamide.

OUTLINE: Participants are randomized to 1 of 6 intervention sequences.

SEQUENCE 1:

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

SEQUENCE 2:

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

SEQUENCE 3:

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

SEQUENCE 4:

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

SEQUENCE 5:

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

SEQUENCE 6:

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

Additionally, all patients undergo urine sample collection during screening and blood sample collection on study.

After completion of study intervention, participants are followed up at 4 and 12 weeks.

Trial PhasePhase I

Trial Typeprevention

Lead OrganizationOhio State University Comprehensive Cancer Center

Principal InvestigatorTheodore L. Wagener

Primary IDOSU-25353
Secondary IDsNCI-2026-00343, STUDY20251872
ClinicalTrials.gov IDNCT07585006

Comparing Electronic Cigarette User Preferences and Smoking Behaviors of Nicotine Analogs to Nicotine to Improve the Understanding of Nicotine Analog Addictiveness

Inclusion Criteria

Exclusion Criteria

United States

Ohio

Columbus

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Comparing Electronic Cigarette User Preferences and Smoking Behaviors of Nicotine Analogs to Nicotine to Improve the Understanding of Nicotine Analog Addictiveness

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