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

• ClinicalTrials.gov Identifier: NCT04956718
• Recruitment Status: Completed
• First Posted: July 9, 2021
• Last Update Posted: March 15, 2022
• Sponsor: University Children's Hospital Basel
• Collaborator: Swiss National Science Foundation
• Information provided by (Responsible Party): University Children's Hospital Basel

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Analgesia	Other: Cold Pressor Test (CPT); Other: Placebo NaCl Nasal spray	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Single centered; national ,randomized, crossover, pilot study
• Masking: Single (Participant)
• Masking Description: participants do not know its a placebo
• Primary Purpose: Basic Science
• Official Title: Breath Metabolomics of Placebo Effects Via Cold Pressor Test
• Actual Study Start Date: October 21, 2021
• Actual Primary Completion Date: January 26, 2022
• Actual Study Completion Date: January 26, 2022

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Switzerland

Universitäts-Kinderspital beider Basel (UKBB)

Basel, Basel-Stadt, Switzerland, 4056

Sponsors and Collaborators

University Children's Hospital Basel

Swiss National Science Foundation

Investigators

• Principal Investigator: Pablo Sinues, Prof. Dr.; Universitäts-Kinderspital beider Basel (UKBB)

More Information

• Responsible Party: University Children's Hospital Basel
• ClinicalTrials.gov Identifier: NCT04956718
• Other Study ID Numbers: 2021-01132; ks21Sinues
• First Posted: July 9, 2021
• Last Update Posted: March 15, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Children's Hospital Basel:

pain; placebo effects; analgesia; placebo analgesia; cold pressor test; breath metabolomics