The Relationships Between the Noradrenergic, Opioid and Pain System

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01851486
First received: May 2, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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 Intervention
Experimental Pain Perception
Drug: Clonidine
Drug: Naloxone
Drug: placebo
Other: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851486

Contacts
Contact: David Yarnitsky, Prof. d_yarnitsky@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: David Yarnitsky       d_yarnitsky@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

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
Study First Received: May 2, 2013
Last Updated: May 9, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 22, 2014