Nicotine Analogs for Addiction
(CENA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how different nicotine-like substances in e-cigarettes affect user preferences and smoking habits. The researchers aim to understand the addictiveness of these nicotine analogs (compounds similar to nicotine) compared to regular nicotine. Participants will try e-cigarettes with various substances, including 6-Methyl Nicotine and nicotinamide, over three visits to determine their preferences. Ideal participants are current e-cigarette users who have vaped for at least three months and are willing to abstain from all nicotine products for at least 12 hours before each lab visit. As a Phase 1 trial, this research seeks to understand how these substances work in people, offering participants a chance to contribute to groundbreaking knowledge.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must abstain from using any nicotine, tobacco, or marijuana products for at least 12 hours before each lab visit.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study raised safety concerns about 6-methyl nicotine (6-MN). Some reports suggest it might cause more cell damage and be more addictive than regular nicotine, indicating that 6-MN could be riskier. However, further research is needed to confirm this.
Conversely, nicotinamide, another substance tested in these trials, is "Generally Recognized as Safe" (GRAS) by the FDA for use in foods. While this designation does not guarantee safety for inhalation, it suggests a lower risk compared to unknown substances.
As this trial is in the early stages, the primary goal is to assess the safety of these treatments in humans. Consequently, there is limited information on their safety in people. Prospective participants should understand these risks before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore nicotine analogs like 6-Methyl Nicotine and nicotinamide, which could offer new ways to tackle nicotine addiction. Unlike traditional nicotine replacement therapies such as patches or gum, which primarily deliver nicotine itself, these analogs might engage different pathways in the brain, potentially reducing cravings and withdrawal symptoms more effectively. Moreover, the study uses an electronic cigarette (EC) method for delivery, allowing controlled administration and greater flexibility for participants, which could lead to better adherence and outcomes. These features make the approach unique compared to existing options.
What evidence suggests that this trial's treatments could be effective for nicotine addiction?
Research has shown that 6-Methyl Nicotine (6-MN) acts like nicotine and might even be stronger, suggesting it could cause similar addictive feelings. In this trial, participants will experience 6-MN in different sequences to assess its effects. Meanwhile, researchers are promoting nicotinamide as a nicotine replacement, but its mechanisms remain less understood. Some studies suggest it might serve as a good substitute, but sufficient proof is lacking. Participants in this trial will also experience nicotinamide in various sequences to evaluate its potential as a nicotine substitute. Overall, the trial aims to determine if both 6-MN and nicotinamide can mimic nicotine's effects.26789
Who Is on the Research Team?
Theodore L Wagener, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 21 or older who have used electronic cigarettes (ECs) regularly for at least the past 3 months. Participants must be able to read, write, and speak English, provide consent, and agree not to use nicotine, tobacco, or marijuana products for at least 12 hours before each lab visit.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to different sequences of nicotine and nicotine analogs, with each sequence involving three visits where participants take puffs of ECs and are monitored for subjective effects and pharmacokinetics.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 4 and 12 weeks.
What Are the Treatments Tested in This Trial?
Interventions
- 6-Methyl Nicotine
- nicotinamide
- Nicotine
Trial Overview
The study compares how EC users respond to nicotine analogs versus regular nicotine by observing their preferences and smoking behaviors. It involves using different substances in EC devices and collecting data through surveys and biospecimen samples during several lab visits.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
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. Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Citations
6-Methyl nicotine and nicotine have similar ...
Overall, these data suggest that the behavioral effects of 6-MN are likely to be highly similar to those of nicotine. It has been previously ...
NCT07585006 | Comparative Evaluation of Nicotine Analogs
To assess the subjective effects and behavioral economic demand of 6-methyl nicotine (6-MN) and nicotinamide. II. To assess the use topography ...
Toxicity, Chemistry, and Public Health Relevance of Emerging ...
Additionally, emerging toxicological evidence indicates that 6-MN is more potent than nicotine to cause oxidative, inflammatory, and toxic responses. This ...
6-Methyl Nicotine E-Cigarettes for Smoking
e-Cigarettes with or without nicotine were as effective as nicotine patches in achieving 6-month smoking cessation. Notably, cessation rates were quite low in .
5.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/Introduction-of-nicotine-analogue-containing-oral-pouch-nproducts-in-the-United-States,195621,0,2.htmlIntroduction of nicotine analogue-containing oral pouch ...
In preclinical studies, 6MN was found to be at least three times more potent than nicotine at eliciting characteristic behaviors, with a lower ...
Emerging nicotine analog 6-methyl nicotine increases ...
Given the potential risks associated with 6-MN, it cannot be deemed 'safer' than nicotine. Therefore, further primary toxicological research is urgently needed ...
Health Risk Assessment for an Unregulated Neurotoxic ... - PMC
This suggests that products containing 6MN have higher abuse potential and an elevated risk of adverse events. This study quantified 6MN in emerging OPPs and ...
6-methylnicotine in e-cigarettes: Insufficient data available
Some results from the few studies available suggest that 6-methylnicotine could be more addictive than nicotine. In order to improve the data available for ...
Nicotine Analogues in Oral Pouch Products and ...
6MN was detected in pouches at concentrations of 4.0% to 16.5% of the stated analogue dose on labels. Nicotinamide was not detected in any pouch ...
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