BMPE: Breath Metabolomics of Placebo Effects, a Pilot Study

Sponsor

University Children's Hospital Basel (Other)

Overall Status

Completed

CT.gov ID

NCT04956718

Collaborator

Swiss National Science Foundation (Other)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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	N/A

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

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single centered; national ,randomized, crossover, pilot studySingle 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 :

Oct 21, 2021

Actual Primary Completion Date :

Jan 26, 2022

Actual Study Completion Date :

Jan 26, 2022

Arms and Interventions

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

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)

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)

Other: Placebo NaCl Nasal spray

placebo nasal spray containing NaCl solution

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.