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Study of cytisinicline and moxifloxacin effects on heart electrical activity in healthy smokers with nicotine addiction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effects of cytisinicline, a medication being tested for nicotine addiction. The research compares cytisinicline with moxifloxacin and placebo to understand how the medication affects heart function in people who smoke. The study focuses specifically on evaluating the heart's electrical activity in healthy smokers.

The study involves taking film-coated tablets of cytisinicline at different dose levels to see how the medication affects the heart's rhythm. During the study, participants receive different treatments across four separate periods. The treatments include cytisinicline at regular and higher doses, moxifloxacin, and placebo. The medication is taken by mouth.

The main purpose is to check if cytisinicline causes any changes in the heart's electrical patterns compared to when taking no medication. This is important to ensure the safety of the medication for people trying to quit smoking. The study measures various aspects of heart activity through electrocardiogram recordings, which are tests that show how the heart is beating.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
As a participant, you will be evaluated to confirm that you smoke at least 10 cigarettes per day and are between 18-45 years old.
Your body mass index (BMI) must be between 18-30.
A blood test will be performed to check your general health status.
Step 2
Study medication administration
You will receive four different treatments over separate periods:
- Cytisinicline at regular dose (tablets)
- Cytisinicline at higher dose (tablets)
- Moxifloxacin (Avelox) 400 mg film-coated tablets
- Placebo (inactive tablets)
Each tablet must be swallowed whole, without breaking, cutting, or chewing
Step 3
Heart monitoring
Your heart activity will be monitored through electrocardiogram (ECG) recordings
The test will measure:
- Heart rate
- Electrical signals in your heart
- Changes in heart rhythm patterns
Step 4
Blood sampling
Blood samples will be collected to measure the amount of cytisinicline in your blood
These measurements will be compared with your heart monitoring results
Step 5
Study duration
The study is conducted from October 29, 2022, to November 23, 2022
You must continue smoking your usual amount of cigarettes (minimum 10 per day) throughout the study period

Who can join the trial?

11 criteria

You must be between 18 and 45 years old
You must currently smoke at least 10 cigarettes per day
You must be in generally good health
Your body mass index (BMI) must be between 18 and 30 kg/m² (BMI is a measure of body fat based on height and weight)
Your blood test results must be within normal ranges
If you are a woman who can become pregnant, you must:
- Use an approved birth control method starting 4 weeks before the study
- Continue using birth control until the last study medication is given
- You must be able to swallow whole tablets without breaking or crushing them
- You must be willing to:
  - Communicate with the study team
  - Follow all study procedures
  - Sign an informed consent form

Who cannot join the trial?

15 criteria

History of heart problems including abnormal heart rhythm, heart failure, or previous heart attacks
Current use of medications that affect heart rhythm (called QT-prolonging drugs)
Severe liver or kidney disease
Pregnancy or breastfeeding
Uncontrolled high blood pressure (readings consistently above 140/90)
Current participation in other clinical trials or within past 30 days
History of allergic reactions to similar medications
Current use of medications to quit smoking (like nicotine patches or varenicline)
Substance abuse or alcohol dependence in the past 12 months
Major psychiatric disorders that are not well-controlled
Blood test results showing significant abnormalities
Body Mass Index (BMI) outside the range of 18-35
Less than 10 cigarettes smoked per day
Unable to provide informed consent
Medical conditions that could interfere with the study medication absorption

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Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
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Porto, Portugal

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Investigated drugs

Cytisinicline is a medication being studied to help people quit smoking. It works by binding to nicotine receptors in the brain, which can help reduce cravings and withdrawal symptoms when someone stops smoking. This medication is designed to make it easier for smokers to quit by lessening their dependence on nicotine. The study specifically looks at how this medication affects the electrical activity of the heart in healthy smokers.

What is already known about the treatment

Cytisinicline - A smoking cessation medication administered orally that helps people overcome nicotine addiction by binding to nicotinic acetylcholine receptors in the brain, similar to how nicotine works but with less addictive potential. This substance, currently undergoing clinical trials, acts as a partial agonist at nicotine receptors, which helps reduce both the pleasure from smoking and withdrawal symptoms when quitting. The medication belongs to the class of smoking cessation aids and is being studied for its safety profile, particularly its effects on cardiac function, with special attention to its impact on heart rhythm (QT intervals) at both therapeutic and higher doses in smokers.

Investigated diseases

Nicotine Addiction - A chronic condition that develops when a person becomes dependent on nicotine, a chemical compound found in tobacco products. The addiction involves both physical and psychological components, with the brain developing a need for regular nicotine intake. When a person uses tobacco products regularly, their body adapts to the presence of nicotine, leading to tolerance and requiring increasing amounts to achieve the same effects. The condition is characterized by strong cravings, difficulty controlling tobacco use, and withdrawal symptoms when attempting to stop. Physical dependence is accompanied by changes in brain chemistry that affect mood, attention, and cognitive function.