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Experimental hypothermia using cold ambient temperature and drug-induced inhibition of shivering in awake, healthy volunteers: a crossover, double blinded trial
EU CTIS ID: 2023-506020-81-00
What this study is testing
We aim to reduce core temperature by lowering ambient temperature utilizing a climate chamber and administrating meperidine and buspirone to inhibit shivering. We will measure difference in temperature (active drug vs. placebo) at termination.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. The participants will be asked to fill out a health-report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the IMPs used.
- BMI under 30 kg/m2
- Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and 2.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
You likely can't join if
- Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidin, klorpromazine, fenytoin, erythromycin, itrakonazol, platelet inhibitors, apomorfin, alcohol (during the trial period) or other opioids (during the trial period). A history of drug dependency.
- Recent head injury, increased ICP, seizures or epilepsy.
- Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, Myasthenia gravis. Previous abdominal surgery. History of cold injuries or frostbites.
- Planned MRI the next two days after ingestion of temperature capsule.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.