The Relationships Between the Noradrenergic, Opioid and Pain System

October 1, 2017 updated by: d_yarnitsky, Rambam Health Care Campus
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 1, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0393-12-RMB.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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