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The Effect of Morphine on the Human Central Nervous System

Phase 1
Conditions
Healthy volunteers (Brain response to i.v. morphine)
Therapeutic area: Body processes [G] - Physiological processes [G07]
Registration Number
EUCTR2016-002623-29-DK
Lead Sponsor
Aalborg Universitets Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

-Male
-20-40 years of age
- Able to read and understand Danish and English
- Male of Northern European descent (in order to minimize genetic variance in the study population)
- Healthy as assessed by a medical doctor at the initial visit
- Opioid naïve
- Non-smoker
- Normal body-mass-index (18.5 to 24.9)
- Signed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Female
- Recieving current medication/prescribed or recreational
- Expected need of medicanl/surgical treatment during the course of the study
- History of psychiatric illness
- Currently in pain
- History of addiction/drug abuse
- Smoker
- Use of any analgesic medication within 24 hours before start
- History of persistant pain
- Known hypersensitivity in the study or pharmaceutical compaunds similar to those used in the study
- Participation in other studies within 14 days prioir to visit
- Any disease or conditions, which investigator assesses will affect the study

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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