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Completed

NCT Number: NCT04956718

Breath Metabolomics of Placebo Effects, a Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Kinderspital beider Basel (UKBB)

Basel, Canton of Basel-City, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female and male adult volunteers
  • German speaking, or good knowledge of the German language
  • Able to understand the study
  • Able to give informed consent

Exclusion criteria

  • Regularly taking medication potentially interfering with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers)
  • Current pregnancy
  • Daily smokers (as per WHO definition: A daily smoker is someone who smokes any tobacco product at least once a day.)
  • Neuropathy
  • Chronic pain
  • Neuromuscular or psychiatric disease
  • Known or suspected heart, kidney or liver disease
  • Hypertension (Systolic (mmHg) >130, Diastolic (mmHg) >80)
  • History of fainting or seizures
  • History of Frostbite
  • Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment.

Treatment and study plan

Cold Pressor Test (CPT)

Other

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.

Placebo NaCl Nasal spray

Other

placebo nasal spray containing NaCl solution

Primary outcomes

  1. change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites

    Time frame: 1 hour

    The variable of primary interest is the variation of signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites.

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Breath Metabolomics of Placebo Effects Via Cold Pressor Test

Acronym: BMPE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2021
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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