Clinical trial NCT04956718: Breath Metabolomics of Placebo Effects, a Pilot Study
Official title: Breath Metabolomics of Placebo Effects Via Cold Pressor Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: pain
placebo effects
analgesia
placebo analgesia
cold pressor test
breath metabolomics
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2021-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single centered; national ,randomized, crossover, pilot study
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel (UKBB)
state: Basel-Stadt
Study officials:
affiliation: Universitäts-Kinderspital beider Basel (UKBB)
name: Pablo Sinues, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: