Breath Metabolomics of Placebo Effects, a Pilot Study

NCT ID: NCT04956718

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-21
• Study Completion Date: 2022-01-26

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Cold Pressor Test (CPT)

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Group Type: OTHER

Cold Pressor Test (CPT)

Intervention Type: OTHER

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

Intervention Type: OTHER

placebo nasal spray containing NaCl solution

Interventions

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.

Intervention Type: OTHER

Placebo NaCl Nasal spray

placebo nasal spray containing NaCl solution

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Children's Hospital Basel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Sinues, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderspital beider Basel (UKBB)

Locations

Universitäts-Kinderspital beider Basel (UKBB)

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2021-01132; ks21Sinues

Identifier Type: -

Identifier Source: org_study_id