NCT04956718

Breath Metabolomics of Placebo Effects, a Pilot Study

Breath Metabolomics of Placebo Effects Via Cold Pressor Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Children's Hospital Basel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.

Detailed description

Interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as Cold Pressure Test (CPT). CPT reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.To this end, probands will be continuously connected to a Heartrate \& Blood Pressure Monitor. First, baseline exhalation will be assessed. Then, the CPT is performed according to the 'CPT Guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (NaCl nasal spray). After 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). The process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.

Conditions

• Analgesia

Interventions

Type	Name	Description
OTHER	Cold Pressor Test (CPT)	Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time.
OTHER	Placebo NaCl Nasal spray	placebo nasal spray containing NaCl solution

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2021-07-09
• Last updated: 2022-03-15

Locations

1 site across 1 country: Switzerland