Breath Metabolomics of Placebo Effects, a Pilot Study (BMPE)

Breath Metabolomics of Placebo Effects Via Cold Pressor Test

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Other: Cold Pressor Test (CPT); Other: Placebo NaCl Nasal spray

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4056
      • Universitäts-Kinderspital beider Basel (UKBB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CPT first; 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. All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa.	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
Other: CPT+placebo first; Participant will be told and read about the 'pain medication' (= Placebo NaCl Nasal spray). Thereafter participant will self-administer a nasal spray, which is in fact a placebo nasal spray containing NaCl solution and Cold Pressor Test (CPT) is performed. All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Pablo Sinues, Prof. Dr., Universitäts-Kinderspital beider Basel (UKBB)

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pain; analgesia; cold pressor test; placebo effects; breath metabolomics; placebo analgesia
• Other Study ID Numbers: 2021-01132; ks21Sinues

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No