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Study on Reducing Body Temperature in Healthy Volunteers Using Pethidine and Buspirone to Prevent Shivering

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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 studying hypothermia, a condition where the body temperature drops below the normal level. The study aims to explore how lowering the surrounding temperature and using specific medications can help manage this condition. The medications being tested include meperidine and buspirone, which are used to prevent shivering, a natural response of the body to cold. Additionally, a placebo is used for comparison purposes.

The purpose of the study is to see how effective these medications are in reducing body temperature without causing shivering. Participants will be exposed to a cold environment in a controlled setting, and their body temperature will be monitored throughout the process. The study will compare the effects of the active medications against the placebo to determine their effectiveness in managing hypothermia.

During the study, participants will receive the medications through different methods, such as intravenous (directly into the vein) or oral (by mouth) administration. The study will last for a short period, and participants will be closely monitored for any changes in their body temperature and overall health. The goal is to gather information on how these treatments can help manage hypothermia safely and effectively.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on your age, health status, and other criteria. Female participants of childbearing potential will take a pregnancy test to confirm the absence of pregnancy.

    You will be asked to sign an informed consent form, which includes compliance with the study requirements and restrictions.

  2. Step 2

    First trial session

    In the first session, you will be exposed to a cold environment in a climate chamber. The goal is to reduce your core temperature.

    You will receive medications to inhibit shivering. These include meperidine and buspirone. Meperidine will be administered intravenously, and buspirone will be taken orally.

    Your temperature will be closely monitored. The session will end if your temperature reaches 35°C, if cooling exceeds 3 hours, or if there are technical issues.

  3. Step 3

    Second trial session

    The second session will be similar to the first, but you may receive a placebo instead of the active medications. A placebo is a substance with no therapeutic effect, used as a control in testing new drugs.

    As in the first session, your temperature and other vital signs will be monitored. The session will end under the same conditions as the first.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your temperature will be measured using a Body CAP capsule as a backup method.

    Other measurements will include respiratory rate, blood pressure, heart rate, and skin temperature. You will also be asked about any discomfort, pain, or nausea experienced during the sessions.

    After each session, your condition will be monitored for any adverse effects or reactions to the medications.

Who can join the trial?

5 criteria

  • Participant must be over 18 and under 40 years of age at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by their medical history. This means participants should feel well, not use any important medication, and have no significant allergies or hypersensitivity to the active substances or any of the other ingredients used in the study drugs.
  • BMI (Body Mass Index) must be under 30 kg/m2. BMI is a measure that uses your height and weight to work out if your weight is healthy.
  • Both male and female participants can be included. Female participants who can have children will be asked to take a pregnancy test to confirm they are not pregnant before receiving the study drug on both visit 1 and 2.
  • Capable of giving signed informed consent, which means you understand the study and agree to follow the rules and restrictions listed in the informed consent form and in this study plan.

Who cannot join the trial?

8 criteria

  • Patients with a history of **allergic reactions** to the study drugs cannot participate. An allergic reaction is when your body has a bad response to a substance, like a rash or trouble breathing.
  • Individuals who are currently taking medications that might interfere with the study drugs are not eligible. This means if you are on certain medicines that could change how the study drugs work, you cannot join.
  • People with **severe liver or kidney disease** are excluded. The liver and kidneys are important organs that help process and remove substances from the body.
  • Participants who have a history of **substance abuse** are not allowed. Substance abuse refers to the harmful use of drugs or alcohol.
  • Women who are pregnant or breastfeeding cannot take part in the study. Pregnancy and breastfeeding involve carrying a baby and feeding a baby with milk from the mother.
  • Individuals with **uncontrolled high blood pressure** are excluded. High blood pressure is when the force of your blood against your artery walls is too high, and uncontrolled means it is not being managed well with treatment.
  • People with a history of **seizures** are not eligible. A seizure is a sudden, uncontrolled electrical disturbance in the brain that can cause changes in behavior, movements, feelings, or consciousness.
  • Anyone with a **mental health condition** that might interfere with their ability to participate in the study is excluded. Mental health conditions affect your mood, thinking, and behavior.
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Investigated drugs

  • Meperidine

    is a medication used in this trial to help reduce shivering. Shivering is a natural response of the body to cold, and it can make it difficult to lower the body's core temperature. By using meperidine, the trial aims to prevent shivering, allowing the body to cool down more effectively when exposed to a cold environment.

  • Buspirone

    is another medication used in the trial to help control shivering. Like meperidine, buspirone is intended to stop the body's natural shivering response to cold. This helps the researchers achieve their goal of lowering the body's core temperature by using a cold environment, without the interference of shivering.

What is already known about the treatment

  • Meperidine

    Meperidine is administered orally or by injection and is used in this trial to help reduce shivering in participants exposed to cold temperatures. It is a well-known medication in the medical field, primarily used for pain relief, but in this study, it is being explored for its ability to inhibit shivering. The main therapeutic indication in this trial is to assist in lowering body temperature by preventing the body's natural response to cold, which is shivering. At the molecular level, meperidine works by binding to opioid receptors in the brain, which helps to reduce the sensation of pain and can also affect the body's temperature regulation. It is classified pharmacologically as an opioid analgesic.

  • Buspirone

    Buspirone is taken orally and is being used in this trial to help prevent shivering in participants exposed to cold environments. It is commonly known in medicine as an anti-anxiety medication, but in this study, it is being tested for its potential to reduce shivering. The main therapeutic indication here is to aid in lowering body temperature by stopping the body's natural shivering response to cold. On a molecular level, buspirone works by affecting neurotransmitters in the brain, particularly serotonin, which can influence mood and body temperature regulation. It is classified pharmacologically as an anxiolytic, specifically a serotonin receptor agonist.

Investigated diseases

Hypothermia – Hypothermia is a condition where the body loses heat faster than it can produce it, causing a dangerously low body temperature. It occurs when the core body temperature drops below 35°C (95°F). As the body temperature decreases, the body's systems begin to slow down, affecting the heart, nervous system, and other organs. Initial symptoms include shivering, confusion, and fatigue. If the condition progresses, shivering may stop, and the person may experience slurred speech, weak pulse, and shallow breathing. Severe hypothermia can lead to unconsciousness and requires immediate medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506020-81-00Estimated enrolment16 patientsSponsorHelse Bergen HF

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