Breath Metabolomics of Placebo Effects, a Pilot Study

Analgesia Clinical Trial

— BMPE  

Official title:

Breath Metabolomics of Placebo Effects Via Cold Pressor Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956718
• Other study ID #: 2021-01132; ks21Sinues
• Status: Completed
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: March 2022
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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.
• Placebo NaCl Nasal spray
placebo nasal spray containing NaCl solution

Locations

Country	Name	City	State
Switzerland	Universitäts-Kinderspital beider Basel (UKBB)	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Children's Hospital Basel	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites	The variable of primary interest is the variation of signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites.	1 hour