Study on Nicotine Freshmint Mouthspray for E-cigarette Users Looking to Quit

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What is this study about?

This clinical trial is focused on helping people who use e-cigarettes and want to quit. The study will test a treatment called Nicotine Freshmint Mouthspray, which is a spray used in the mouth that contains nicotine. The trial will compare this spray to a similar spray that looks the same but does not contain nicotine, known as a placebo. The main goal of the study is to see how effective the Nicotine Freshmint Mouthspray is in helping people stop using e-cigarettes.

Participants in the study will be randomly assigned to use either the Nicotine Freshmint Mouthspray or the placebo. The study will last for several weeks, during which participants will visit the clinic at different times to check their progress. These visits will help researchers understand how well the spray works and if there are any side effects. Participants will be asked to report if they have stopped using e-cigarettes and if they have any cravings or withdrawal symptoms.

The study will also monitor the safety of the Nicotine Freshmint Mouthspray by collecting information on any adverse events reported by participants. This information will help determine if the spray is safe to use. The trial aims to provide valuable insights into whether the Nicotine Freshmint Mouthspray can be an effective aid for people looking to quit e-cigarettes.

1 initial visit

Upon joining the study, participants will attend an initial visit. During this visit, participants will be informed about the study details and will sign a consent form to confirm their willingness to participate.

Participants will undergo an assessment to ensure they meet the study’s eligibility criteria, which includes being a healthy individual over 18 years old, having a history of daily nicotine intake from vaping for at least 3 months, and a strong motivation to quit nicotine.

2 randomization

Participants will be randomly assigned to one of two groups: one group will receive the Nicotine Freshmint Mouthspray, and the other group will receive a placebo mint mouthspray that looks the same but does not contain nicotine.

This process is double-blind, meaning neither the participants nor the researchers will know which group the participants are in.

3 treatment phase

Participants will use the assigned mouthspray as directed. The mouthspray is administered oromucosally, which means it is sprayed into the mouth.

The dosage and frequency of use will be explained during the initial visit, and participants are expected to follow these instructions throughout the study.

4 follow-up visits

Participants will attend regular follow-up visits at weeks 2, 4, 6, 12, 26, 30, and 52. During these visits, participants will report their progress and any side effects they may experience.

The study will monitor participants’ abstinence from e-cigarettes and verify this through various tests, including checking for nicotine by-products in the body.

5 daily diary

Participants will be required to keep a daily electronic diary (eDiary) to record their urge to vape, any e-cigarette use, and the number of mouthspray doses taken.

This diary helps track progress and any withdrawal symptoms experienced during the study.

6 safety monitoring

Throughout the study, participants’ safety will be closely monitored. Any adverse events or side effects should be reported immediately.

The study team will evaluate and analyze these reports to ensure participant safety.

7 end of study

The study is expected to conclude by February 2026. Participants will have a final visit to assess their overall progress and any long-term effects of the treatment.

Participants will receive information on further support for maintaining nicotine abstinence after the study ends.

Who Can Join the Study?

The participant must have signed and dated the informed consent document before taking part in any trial-specific procedures. This means they have been informed about all important aspects of the trial.
The participant must be able to understand the trial requirements and be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other trial procedures.
The participant must be a healthy individual aged 18 years or older. Healthy means there are no significant health issues as determined by the trial investigator.
The participant must have a history of using nicotine from vaping daily for at least 3 months before the screening visit.
The participant must have a strong desire to quit nicotine, with a motivation level rated as ‘high’ to ‘very high’ based on a screening assessment.
The participant must be classified as either moderately or highly dependent on e-cigarettes, with a score of 9 or greater on the Penn State Electronic Cigarette Dependence Index (PS-ECDI).
The participant must be an exclusive e-cigarette user, meaning they do not use other forms of tobacco or nicotine products.
For females: The participant must be in a postmenopausal state (no menstrual periods for at least 1 year without another medical reason) or, if premenopausal or perimenopausal, must use an effective form of contraception.
For males: The participant must not have a pregnant or breastfeeding partner at the time of screening and must agree to use an acceptable form of birth control with their partner during the trial and for 30 days after.
The participant must be able to read and understand the local language.

Who Cannot Join the Study?

Patients who are not willing to stop using e-cigarettes during the study.
Patients who have a known allergy or sensitivity to nicotine or any ingredients in the mouth spray.
Patients who are currently participating in another clinical trial.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have used any other smoking cessation products in the last 30 days.
Patients who have a history of heart disease or uncontrolled high blood pressure.
Patients who have a history of mental health disorders that are not well controlled.
Patients who are under the age of 18 or over the age of 65.
Patients who are unable to understand or follow the study instructions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Klinische Forschung Berlin GbR	Berlin	Germany
Clinical Research Hamburg GmbH	Hamburg	Germany
Medizentrum Essen Borbeck	Essen	Germany
Krraxxwc dec Uefgioezhhwz Mufybjyg Apu	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	17.01.2024

Trial locations

Investigated drugs:

Nicotine

Nicotine Freshmint Mouthspray is a type of nicotine replacement therapy designed to help people who want to quit using e-cigarettes. It comes in the form of a mouth spray with a fresh mint flavor. The spray delivers a small amount of nicotine into the mouth, which is absorbed through the lining of the mouth. This helps to reduce cravings and withdrawal symptoms that people often experience when they stop using e-cigarettes. The goal of using this mouth spray is to make it easier for people to quit e-cigarettes by providing a controlled amount of nicotine without the harmful effects of smoking or vaping.

Nicotine Dependence – Nicotine dependence is a condition characterized by an addiction to nicotine, a chemical found in tobacco products, including e-cigarettes. It develops as nicotine alters brain chemistry, leading to cravings and withdrawal symptoms when not consumed. Over time, individuals may require increasing amounts of nicotine to achieve the same effects, reinforcing the cycle of addiction. The progression of nicotine dependence can lead to habitual use, making it challenging to quit. Withdrawal symptoms can include irritability, anxiety, difficulty concentrating, and increased appetite. The condition often requires behavioral changes and support to overcome.

Trial ID:

2023-505036-35-00

Protocol code:

CCSSMC005220

Trial Phase:

Therapeutic confirmatory (Phase III)

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