The Relationships Between the Noradrenergic, Opioid and Pain System

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01851486

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Experimental Pain Perception	Drug: Clonidine Drug: Naloxone Drug: placebo Other: saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clonidine+ Saline Clonidine 0.15 mg and saline 0.15 mg/kg	Drug: Clonidine Clonidine 0.15 mg Other: saline
Active Comparator: Clonidine + Naloxone Clonidine 0.15 mg and Naloxone 0.15 mg/kg	Drug: Clonidine Clonidine 0.15 mg Drug: Naloxone naloxone 0.15 mg/kg
Active Comparator: Placebo +Naloxone Placebo 0.15 mg+ naloxone 0.15 mg/kg	Drug: Naloxone naloxone 0.15 mg/kg Drug: placebo
Placebo Comparator: Placebo +saline Placebo 0.15 mg+ saline 0.15 mg/kg	Drug: placebo Other: saline

Outcome Measures

Primary Outcome Measures

The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers
Age 18-40
No chronic disease

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

d_yarnitsky, Professor, Head on Neurology Department, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01851486

Other Study ID Numbers:

0393-12-RMB.CTIL

First Posted:

May 10, 2013

Last Update Posted:

Oct 4, 2017

Last Verified:

Oct 1, 2017

Additional relevant MeSH terms:

Clonidine

Naloxone

Study Results

No Results Posted as of Oct 4, 2017