The Effect of Morphine on the Human Central Nervous System

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002623-29-DK

Enrollment

Unknown

Registered

2016-06-30

Start date

2016-08-29

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (Brain response to i.v. morphine)

Interventions

Trade Name: Morphine Product Name: Morphine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: morphinhydrochlorid CAS Number: 57-27-2 Other descriptive name: MORPHINE Concentr

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The project aims to investigate the effect of I.V. morphine on the central nervous system (including spinal cord and the brain) and to observe whether these effects are reversed by an opioid-receptor blocker (naloxone).;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be to evaluate potential central changes due to morphine (as measured from the spontaneous EEG, withdrawal reflex, spinal evoked potentials, cortical evoked potentials) as compared to post naloxone administration and placebo.;Timepoint(s) of evaluation of this end point: 4 times on each visit: - At baseline - 15 min. after i.v. morphine infusion start - 2 min. after infusion stop - 1 hour after infusion stop.	—

Measure

Time frame

Main Objective: The project aims to investigate the effect of I.V. morphine on the central nervous system (including spinal cord and the brain) and to observe whether these effects are reversed by an opioid-receptor blocker (naloxone).;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be to evaluate potential central changes due to morphine (as measured from the spontaneous EEG, withdrawal reflex, spinal evoked potentials, cortical evoked potentials) as compared to post naloxone administration and placebo.;Timepoint(s) of evaluation of this end point: 4 times on each visit: - At baseline - 15 min. after i.v. morphine infusion start - 2 min. after infusion stop - 1 hour after infusion stop.

—

Secondary

Measure	Time frame
Secondary end point(s): Pupillometry Pain catastrophizing scale ;Timepoint(s) of evaluation of this end point: Pain catastrophizing scale: at baseline Pupillometry: 4 times on each visit - At baseline - 15 min. after i.v. morphine infusion start - 2 min. after infusion stop - 1 hour after infusion stop	—

Countries

Denmark

Contacts

Public ContactMech-Sense

Mech-Sense, Aalborg University Hospital

dile@rn.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026