Ongoing Clinical Trials for Nicotine Dependence
Currently, there are 2 ongoing clinical trials testing new approaches to help people overcome nicotine dependence. These studies are taking place in Poland and Germany, and they focus on helping both traditional cigarette smokers and e-cigarette users to quit. The trials are testing different types of nicotine replacement therapies and alternative medications to find the most effective ways to support people in quitting nicotine.
Clinical trial locations
- Germany
- Poland
Study Comparing Cytisinicline and Nicotine Therapy for Patients with Nicotine Dependence and Chronic Kidney Disease
This trial is designed specifically for people who smoke cigarettes daily and also have chronic kidney disease. It compares two different treatment approaches: a medication called Cytisine and various forms of Nicotine Replacement Therapy, including patches and lozenges.
Who can participate:
- Adults aged 18 to 64 years who want to quit smoking
- People who have been smoking daily or almost daily for at least 3 months
- Individuals with chronic kidney disease at stage 3 or higher, meaning their kidney function has been reduced for at least 3 months
- Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during treatment
- Participants must have access to a telephone and be willing to attend regular check-ups
Who cannot participate:
The trial excludes people who already have severe complications from chronic kidney disease that would make participation unsafe.
What the trial involves:
Participants are randomly assigned to receive either Cytisine tablets or Nicotine Replacement Therapy products. The Nicotine Replacement Therapy group may use patches that deliver nicotine through the skin, as well as fruit or mint-flavored lozenges. The study lasts for 12 weeks of active treatment, with follow-up assessments at 3 and 6 months to measure success in quitting smoking.
Investigational treatments:
Cytisine is a plant-based medication that helps reduce nicotine cravings and withdrawal symptoms. It works by acting on the same receptors in the brain that nicotine affects, making it easier to quit smoking. Nicotine Replacement Therapy provides controlled, low doses of nicotine without the harmful chemicals found in tobacco smoke, helping to ease the transition away from cigarettes.
Study on Nicotine Freshmint Mouthspray for E-cigarette Users Looking to Quit
This trial focuses on helping people who use e-cigarettes and want to quit vaping. It tests a mint-flavored nicotine mouth spray against a placebo spray that looks identical but contains no nicotine.
Who can participate:
- Healthy adults aged 18 years or older
- People who have been vaping daily for at least 3 months before joining the study
- Individuals with a strong desire to quit nicotine use
- Those who are moderately or highly dependent on e-cigarettes, as measured by a dependence assessment
- Exclusive e-cigarette users who do not use other tobacco or nicotine products
- Participants must be able to read and understand the local language and keep a daily electronic diary
Who cannot participate:
- People who are unwilling to stop using e-cigarettes during the study
- Those with known allergies to nicotine or ingredients in the mouth spray
- Pregnant or breastfeeding women
- Individuals with uncontrolled heart disease or high blood pressure
- Those with poorly controlled mental health conditions
- People who have used other smoking cessation products in the last 30 days
What the trial involves:
This is a double-blind study, meaning neither participants nor researchers know who receives the real nicotine spray or the placebo. Participants use the assigned mouth spray as directed and attend regular follow-up visits over the course of one year. These visits occur at weeks 2, 4, 6, 12, 26, 30, and 52. Throughout the study, participants keep a daily electronic diary recording their urges to vape, any e-cigarette use, and how many times they use the mouth spray.
Investigational treatment:
The Nicotine Freshmint Mouthspray delivers a controlled amount of nicotine through the lining of the mouth. This helps reduce cravings and withdrawal symptoms that often occur when people stop vaping. The spray provides nicotine without the potentially harmful effects associated with vaping.
Summary
These two clinical trials represent different approaches to addressing nicotine dependence in distinct populations. One trial focuses on traditional cigarette smokers who also have kidney disease, testing whether a plant-based medication can be as effective as standard nicotine replacement products. The other trial addresses the growing issue of e-cigarette use, exploring whether a nicotine mouth spray can help people quit vaping.
Both studies are taking place in different European countries, with Poland hosting the trial for smokers with kidney disease and Germany conducting the research on e-cigarette users. The trials use different study designs and treatment durations, reflecting the different needs of these two groups. Together, these studies aim to provide more options for people trying to break free from nicotine dependence, whether they smoke traditional cigarettes or use modern e-cigarettes.
