Breath Metabolomics of Placebo Effects, a Pilot Study

NCT04956718 | Completed

• 1 other identifier: 2021-01132; ks21Sinues
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CPT first

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. 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

CPT+placebo first

OTHER

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

Interventions

Cold Pressor Test (CPT) 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.

CPT first; CPT+placebo first

Placebo NaCl Nasal spray OTHER

placebo nasal spray containing NaCl solution

CPT first; CPT+placebo first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Universitäts-Kinderspital beider Basel (UKBB)

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Sinues, Prof. Dr.

  Universitäts-Kinderspital beider Basel (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know its a placebo
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centered; national ,randomized, crossover, pilot study

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: October 21, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

CH (1)