Itch Clinical Trial
Official title:
A Mechanistic Study on Morphine-induced Orthogonal Neural Plasticity for Itch and Pain Processing in Humans (a Relation of Morphine-induced Itch and Pain Processing)
Verified date | July 2020 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In This experiment, the investigators would like to test the two following hypotheses
regarding the mechanisms by which opioids cause itch:
1. Opioids cause itch by a spinal disinhibition mechanism (central nervous system (CNS)
effect).
2. Opioids cause itch through a mast cell-destabilizing effect leading to release of
histamine and tryptase in the skin where itch is evoked (peripheral mechanism).
Status | Completed |
Enrollment | 24 |
Est. completion date | July 7, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy men and women in the age of 20-65 years - The participants must be able to speak and understand English Exclusion Criteria: - Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. - Pregnant or lactating female persons - Drug addiction defined as the use of cannabis, opioids or other drugs - Previous or present neurologic, musculoskeletal or mental illnesses - Current pain and itch causing diseases or psychiatric disorders - Participants unable to understand or follow the instructions - Participating in another study where investigational drug is used - Participants had known allergy/discomfort to morphine - Lack of ability to cooperate |
Country | Name | City | State |
---|---|---|---|
Denmark | Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborg Universitetshospitalet, | AAlborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microvascular reactivity | The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging. | Before and 70 minutes after morphine/placebo administration | |
Primary | Microvascular reactivity | The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging. | 10 minutes after every itch inductions | |
Primary | Assessment of itch | Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'. | 1 minute after every itch inductions | |
Primary | Assessment of pain | Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'. | 1 minute after every itch inductions | |
Secondary | Cold (CPT) and heat (HPT) pain thesholds | Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm. | 10 minutes before morphine/placebo administration | |
Secondary | Cold (CPT) and heat (HPT) pain thesholds | Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm. | 60 minutes after morphine/placebo administration | |
Secondary | Pressure Pain Threshold | Pressure will be applied to the supinator muscle on the left forearm, 15 cm distal to the elbow by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) with a standard probe of 1 cm2. | 10 minutes before morphine/placebo administration | |
Secondary | Pressure Pain Threshold | Pressure will be applied to the supinator muscle on the left forearm, 15 cm distal to the elbow by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) with a standard probe of 1 cm2. | 60 minutes after morphine/placebo administration |
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