The Relationships Between the Noradrenergic, Opioid and Pain System

NCT01851486 | Withdrawn DMC

• 1 other identifier: 0393-12-RMB.CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The role of alpha2 receptor agonist on pain perception and modulation will be examined. In addition whether this is mediated through the opioid system will be examined. Pain perception and modulation will be examined before and after administration of Clonidine or placebo together with Naloxone or saline.

Conditions

Experimental Pain Perception

Outcome Measures

Primary Outcomes (1)

• The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist

  The change in pain perception (pain thresholds and pain ratings of suprathresholds stimuli) and in the excitatory and inhibitory pain modulation responses (assessed by the temporal summation and conditioned pain modulation paradigms) will be examined before and after administration of alpha 2 agonist with and without mu receptor antagonist

  2 years

Study Arms (4)

Clonidine+ Saline

ACTIVE COMPARATOR

Clonidine 0.15 mg and saline 0.15 mg/kg

Drug: Clonidine; Other: saline

Clonidine + Naloxone

ACTIVE COMPARATOR

Clonidine 0.15 mg and Naloxone 0.15 mg/kg

Drug: Clonidine; Drug: Naloxone

Placebo +Naloxone

ACTIVE COMPARATOR

Placebo 0.15 mg+ naloxone 0.15 mg/kg

Drug: Naloxone; Drug: placebo

Placebo +saline

PLACEBO COMPARATOR

Placebo 0.15 mg+ saline 0.15 mg/kg

Drug: placebo; Other: saline

Interventions

Clonidine DRUG

Clonidine 0.15 mg

Clonidine + Naloxone; Clonidine+ Saline

Naloxone DRUG

naloxone 0.15 mg/kg

Clonidine + Naloxone; Placebo +Naloxone

placebo DRUG

Placebo +Naloxone; Placebo +saline

saline OTHER

Clonidine+ Saline; Placebo +saline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Age 18-40
• No chronic disease

You may not qualify if:

• Subjects who suffer from chronic pain / pain syndrome
• use of anti-depressant or anti-psychotic drugs
• suffering from cardiovascular disease
• breast feeding

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Clonidine; Naloxone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: Professor, Head on Neurology Department

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 10, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

IL (1)