AnalgesiaBMPENCT04956718
Breath Metabolomics of Placebo Effects, a Pilot Study
A study testing Cold Pressor Test (CPT) in people with Analgesia, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Cold Pressor Test (CPT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Oct 2021to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Canton of Basel-City, 4056
About this study
Official title: Breath Metabolomics of Placebo Effects Via Cold Pressor Test
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.
Read the 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
- Being tested
- Cold Pressor Test (CPT), Placebo NaCl Nasal spray
- Keywords
- pain, placebo effects, analgesia, placebo analgesia, cold pressor test, breath metabolomics
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo NaCl Nasal sprayOther
placebo nasal spray containing NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Cold Pressor Test (CPT); Other: Placebo NaCl Nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start21 Oct 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single centered; national ,randomized, crossover, pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Pablo Sinues, Prof. Dr., Principal investigator, Universitäts-Kinderspital beider Basel (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956718
- Sponsor's protocol ID
- 2021-01132; ks21Sinues
- Acronym
- BMPE
- Status last verified
- Mar 2022
- First submitted
- 30 Jun 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Metabolomics of Placebo Effects Via Cold Pressor Test
- ClinicalTrials.gov ID
- NCT04956718
- Acronym / sponsor ID
- BMPE / 2021-01132; ks21Sinues
- Conditions
- Analgesia
- Keywords
- pain, placebo effects, analgesia, placebo analgesia, cold pressor test, breath metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single centered; national ,randomized, crossover, pilot study
| Arm | Type | Receives |
|---|---|---|
| CPT first | Other | Other: Cold Pressor Test (CPT), Other: Placebo NaCl Nasal sprayCold 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. |
| CPT+placebo first | Other | Other: Cold Pressor Test (CPT), Other: Placebo NaCl Nasal sprayParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CPT first, CPT+placebo first |
| Placebo NaCl Nasal sprayplacebo nasal spray containing NaCl solution | Other | CPT first, CPT+placebo first |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Sinues, Prof. Dr. principal investigator
Universitäts-Kinderspital beider Basel (UKBB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Pressor Test (CPT) in people with Analgesia, run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.