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The Relationships Between the Noradrenergic, Opioid and Pain System

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ClinicalTrials.gov Identifier: NCT01851486
Recruitment Status : Withdrawn (Labortory focus was changed and study was not opened at all)
First Posted : May 10, 2013
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Actual Study Start Date : January 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851486


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: d_yarnitsky, Professor, Head on Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01851486     History of Changes
Other Study ID Numbers: 0393-12-RMB.CTIL
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Naloxone
Clonidine
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action