A Relation of Morphine-induced Itch and Pain Processing
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)
1 other identifier
interventional
24
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 4, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2020
CompletedJuly 8, 2020
July 1, 2020
4 months
September 30, 2019
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (4)
Cold (CPT) and heat (HPT) pain thesholds
10 minutes before morphine/placebo administration
Cold (CPT) and heat (HPT) pain thesholds
60 minutes after morphine/placebo administration
Pressure Pain Threshold
10 minutes before morphine/placebo administration
Pressure Pain Threshold
60 minutes after morphine/placebo administration
Study Arms (2)
Morphine
ACTIVE COMPARATOREach participant will receive a single dose of 20 mg morphine tablet. At estimated peak-plasma concentration testing is conducted. The subject and the assessor are both blinded to the drug administrations.
Placebo
PLACEBO COMPARATOREach participant will receive a single dose of an identical placebo tablet. At estimated peak-plasma concentration testing is conducted. The subject and the assessor are both blinded to the drug administrations.
Interventions
Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.
25 spicules will be inserted in the centre of the predefined skin area on the forearm. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration
A droplet of saline (0.9%) as vehicle control will be placed on the predetermined area on the forearm and the lancet will be pierced through the droplet.
Eligibility Criteria
You may qualify if:
- Healthy men and women in the age of 20-65 years
- The participants must be able to speak and understand English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborg Universitetshospitalet,
Aalborg, North Denmark, 9000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 4, 2019
Study Start
January 15, 2020
Primary Completion
May 1, 2020
Study Completion
July 7, 2020
Last Updated
July 8, 2020
Record last verified: 2020-07