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Study on the Effects of Nicotine Resinate Lozenge on Cravings in Moderate Smokers in Non-Smoking Situations

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What is this trial about?

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

This clinical trial is focused on helping people who are trying to quit smoking. The study is examining the effects of a nicotine substitute called Nicotine 1.5mg lozenge, which is a small, mint-flavored tablet that dissolves in the mouth. The trial will compare the effects of this lozenge to a placebo, which looks like the lozenge but does not contain any active ingredients. The main goal is to see if the lozenge can help reduce the urge to smoke in people who smoke moderately, which means they smoke between 11 and 20 cigarettes a day.

Participants in the study will be given either the Nicotine 1.5mg lozenge or the placebo. They will take a single dose and then be observed to see how their cravings for cigarettes change over time. The study will look at how cravings are reduced from 30 minutes up to 3 minutes after taking the lozenge. This will help researchers understand if the lozenge is effective in reducing the desire to smoke when people are in situations where they cannot smoke.

The trial is designed to be a fair test, meaning neither the participants nor the researchers will know who is receiving the actual lozenge or the placebo. This is known as a "double-blind" study. The results will help determine if the Nicotine 1.5mg lozenge can be a useful tool for people who want to quit smoking by reducing their cravings in non-smoking situations.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, informed consent is required. This involves understanding the study's purpose and agreeing to participate.

    A negative test for SARs-CoV-2 or its variants is necessary at the start of the study.

  2. Step 2

    Eligibility confirmation

    Eligibility is confirmed based on criteria such as age (18 years or older), body mass index (BMI) between 18.5 and 29.5, and smoking habits (11-20 cigarettes per day).

    Motivation for quitting smoking is assessed using the Richmond test, with a score greater than 7 required.

  3. Step 3

    Initial assessments

    Initial assessments include a questionnaire to evaluate smoking urges and a test for nicotine withdrawal symptoms.

    For women of childbearing potential, a negative pregnancy test is required.

  4. Step 4

    Medication administration

    Participants receive a single dose of a nicotine lozenge (1.5 mg) or a placebo. The lozenge is taken orally.

    The purpose is to evaluate the effect on smoking urges in a non-smoking situation.

  5. Step 5

    Monitoring and evaluation

    The effect of the lozenge on smoking urges is monitored over a period of 30 minutes, with additional assessments at 45, 60, and 90 minutes.

    Participants complete a questionnaire to measure changes in smoking urges and withdrawal symptoms.

  6. Step 6

    End of day evaluation

    At the end of the day, a global evaluation of craving is conducted using a visual scale.

    The number of lozenges used and any adverse effects are recorded.

Who can join the trial?

10 criteria

  • Before participating in the study, you must provide written informed consent, which means you agree to take part after understanding the study details.
  • You must have a negative test result for the virus that causes COVID-19, done at the start of the study and on the first day of the study.
  • You can be either male or female.
  • You must be at least 18 years old.
  • Your Body Mass Index (BMI), which is a measure of body fat based on height and weight, should be between 18.5 and 29.5.
  • You should be a moderate smoker, which means you smoke 11 to 20 cigarettes a day, with a Fagerström score of 5 to 6. The Fagerström score is a way to measure how dependent you are on nicotine.
  • Your time to the first cigarette after waking up should be between 5 and 30 minutes, which corresponds to a score of 2 on the first item of the Fagerström test.
  • Your motivation to quit smoking should be greater than 7 on the Richmond test, which is a way to measure how motivated you are to stop smoking, at the start of the study and on the first day.
  • If you are a woman who can have children, you must have a negative pregnancy test at the start of the study and on the first day if the initial test was done more than 72 hours before the first day.
  • If you are a woman who can have children, you must use an effective method of birth control, such as birth control pills, an intrauterine device (IUD), an implant, surgery to prevent pregnancy, or a barrier method like condoms.

Who cannot join the trial?

3 criteria

  • Individuals who are not moderate smokers.
  • Individuals who are not in the age range specified for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Nicotine Lozenge This medication is used to help reduce cravings for nicotine in moderate smokers who are in situations where they cannot smoke. The lozenge is taken orally and releases a small amount of nicotine to help manage withdrawal symptoms and reduce the urge to smoke.

What is already known about the treatment

Nicotine Lozenge – This medication is administered orally in the form of a lozenge, designed to dissolve slowly in the mouth. It is currently being studied in clinical trials to evaluate its effectiveness in reducing cravings for moderate smokers in non-smoking situations. The main therapeutic indication is to aid in smoking cessation by alleviating the urge to smoke. At the molecular level, nicotine works by binding to nicotinic acetylcholine receptors in the brain, which helps to reduce withdrawal symptoms and cravings. It is classified pharmacologically as a smoking cessation aid.

Investigated diseases

Nicotine Dependence – Nicotine dependence is a condition characterized by an addiction to nicotine, a chemical found in tobacco products. It develops as the brain becomes accustomed to the presence of nicotine, leading to cravings and withdrawal symptoms when not using tobacco. Over time, individuals may require increasing amounts of nicotine to achieve the same effects, reinforcing the cycle of addiction. This dependence can lead to habitual smoking or use of other nicotine products, making cessation challenging. The progression of nicotine dependence involves both physical and psychological components, with cravings often triggered by environmental cues or stress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506787-13-00Protocol codeV00018PC303Estimated enrolment180 patientsSponsorPierre Fabre Medicament

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