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Nicotine Resinate

This article discusses a clinical trial investigating the effectiveness of Nicotine Resinate lozenges in reducing cravings for moderate smokers in non-smoking situations. The study aims to assess the impact of a 1.5mg nicotine lozenge compared to a placebo on smoking urges and withdrawal symptoms. This research is crucial for developing better smoking cessation aids and helping individuals quit smoking more effectively.

Table of Contents

What is Nicotine Resinate?

Nicotine Resinate is an active ingredient used in smoking cessation products, specifically in lozenges designed to help people quit smoking[1]. It is a form of nicotine that is bound to a resin, which allows for a controlled release of nicotine when the lozenge dissolves in the mouth. The product being studied is called “NICOPASS 1.5 mg SANS SUCRE MENTHE FRAICHEUR,” which is a sugar-free, fresh mint flavored lozenge[1].

How Does It Work?

Nicotine Resinate works by providing a small, controlled dose of nicotine to help reduce cravings and withdrawal symptoms that occur when a person stops smoking. When you use a Nicotine Resinate lozenge, it slowly releases nicotine into your body through the lining of your mouth. This helps to satisfy the body’s craving for nicotine without the harmful effects of smoking tobacco[1].

Who Can Use Nicotine Resinate?

Nicotine Resinate lozenges are designed for moderate smokers who are trying to quit. Based on the clinical trial information, the ideal candidates for this treatment are:

  • Adults aged 18 years or older
  • Moderate smokers (11-20 cigarettes per day)
  • Those with a Fagerström score of 5 to 6 (This is a test that measures nicotine dependence)
  • People who smoke their first cigarette between 5 and 30 minutes after waking up
  • Those with a high motivation to quit smoking (scoring >7 on the Richmond test)[1]

How to Use Nicotine Resinate

Based on the clinical trial protocol, here’s how Nicotine Resinate lozenges are typically used:

  1. Take the first lozenge about 30 minutes after breakfast.
  2. Allow the lozenge to dissolve slowly in your mouth. Do not chew or swallow it whole.
  3. Use additional lozenges throughout the day when you feel the urge to smoke.
  4. Wait at least 30 minutes between lozenges.
  5. Do not use more than 20 lozenges per day.[1]

Effectiveness

The clinical trial aims to assess how effective Nicotine Resinate lozenges are in reducing cravings for cigarettes. The researchers are particularly interested in:

  • How quickly the lozenges work (from 30 minutes up to 3 hours after use)
  • How well they reduce cravings throughout the day
  • Their effect on withdrawal symptoms such as anxiety, anger, irritability, difficulty concentrating, restlessness, and depressed mood[1]

Side Effects and Safety

While Nicotine Resinate is generally considered safe for most people trying to quit smoking, it may not be suitable for everyone. The clinical trial excludes people with certain conditions, including:

  • Phenylketonuria (a genetic disorder that affects how the body processes protein)
  • Recent history of heart problems or stroke
  • Epilepsy
  • Asthma or COPD (Chronic Obstructive Pulmonary Disease)
  • Parkinson’s disease
  • Oral health issues
  • Pregnancy or breastfeeding
  • Certain other medical conditions[1]

Always consult with your healthcare provider before starting any new smoking cessation treatment.

Clinical Trial Information

The information provided is based on a clinical trial studying the effects of Nicotine Resinate lozenges. Key points about the trial include:

  • It’s a Phase III clinical trial, which means the treatment has already shown promise in earlier studies.
  • It’s a randomized, double-blind, placebo-controlled study. This means participants are randomly assigned to either the real treatment or a placebo, and neither the participants nor the researchers know who is getting which until the study is over.
  • The study aims to evaluate how well the lozenges work to reduce cravings and withdrawal symptoms in moderate smokers who are trying to quit.
  • The trial is specifically looking at the effects of a 1.5mg nicotine lozenge compared to a placebo.[1]

Remember, while this information is promising, the full results of the clinical trial are not yet available. Always follow the advice of your healthcare provider when considering smoking cessation methods.

Aspect Details
Study Type Randomized, double-blind, placebo-controlled parallel groups trial
Intervention Nicotine Resinate 1.5mg lozenge vs. Placebo
Participants Moderate smokers (11-20 cigarettes/day), aged 18+, motivated to quit
Primary Outcome Reduction in smoking urges measured by QSU-brief score at 30 minutes
Secondary Outcomes Craving reduction at 45, 60, 90 minutes; withdrawal symptoms; overall satisfaction
Duration 24-hour confinement with 3-day follow-up
Maximum Daily Dose Up to 20 lozenges (31.5mg nicotine) over 12 hours
Safety Monitoring Adverse events, physical examinations, vital signs

FAQ

  • What is the main goal of this clinical trial? The main goal is to assess the effectiveness of a single dose of Nicotine 1.5mg lozenge compared to a placebo in reducing cravings for moderate smokers in non-smoking situations, from 30 minutes up to 3 hours after use.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, moderate smokers (11-20 cigarettes/day) with a Fagerström score of 5 to 6, motivated to quit smoking, and meet other specific health criteria. Pregnant women, people with certain medical conditions, or those using other smoking cessation aids are excluded.
  • How long does the trial last? The main part of the trial lasts for 24 hours, during which participants are confined to a smoke-free clinical unit. They quit smoking at 8:00 PM on Day 0 and use the lozenges on Day 1. There is also a follow-up period for safety monitoring up to 3 days after the last lozenge use.
  • What measurements are taken during the trial? The trial measures smoking urges using the Questionnaire of Smoking Urges (QSU)-brief, withdrawal symptoms using the Minnesota Nicotine Withdrawal Scale (MNWS), and overall craving using a Visual Analog Scale (VAS). Safety is also monitored through adverse event reporting.
  • How many lozenges can participants use during the trial? Participants can use up to 20 lozenges on Day 1, starting 30 minutes after breakfast. Lozenges are taken on demand when needed for cravings, with at least 30 minutes between each lozenge. The last lozenge can be taken around 7:00 PM.

Ongoing Clinical Trials on Nicotine Resinate

Glossary

  • Nicotine Resinate: A form of nicotine used in smoking cessation products, such as lozenges, that helps reduce cravings and withdrawal symptoms in smokers trying to quit.
  • Fagerström score: A measure of nicotine dependence in smokers, ranging from 0 to 10. In this study, participants must have a score of 5 to 6, indicating moderate dependence.
  • Questionnaire of Smoking Urges (QSU)-brief: A standardized questionnaire used to assess the intensity of smoking cravings and urges in individuals trying to quit smoking.
  • Minnesota Nicotine Withdrawal Scale (MNWS): A tool used to measure the severity of nicotine withdrawal symptoms, such as anxiety, irritability, and difficulty concentrating, in people who have recently quit smoking.
  • Visual Analog Scale (VAS): A measurement tool used to assess subjective experiences, such as cravings, by having participants mark a point on a continuous line between two endpoints representing extreme values.
  • Double-blind trial: A study design where neither the participants nor the researchers directly involved know who is receiving the active treatment or placebo, to minimize bias in the results.
  • Placebo: An inactive substance that looks like the real treatment but has no therapeutic effect, used as a control in clinical trials to test the effectiveness of the active treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-nicotine-resinate-lozenge-on-cravings-in-moderate-smokers-in-non-smoking-situations/