The Relationships Between the Noradrenergic, Opioid and Pain System

Not Applicable

Withdrawn

• Conditions: Experimental Pain Perception
• Interventions: Drug: Clonidine; Drug: Naloxone; Other: saline; Drug: placebo

• Registration Number: NCT01851486
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-01
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo +saline	saline	Placebo 0.15 mg+ saline 0.15 mg/kg
Clonidine+ Saline	saline	Clonidine 0.15 mg and saline 0.15 mg/kg
Clonidine + Naloxone	Clonidine	Clonidine 0.15 mg and Naloxone 0.15 mg/kg
Placebo +Naloxone	Naloxone	Placebo 0.15 mg+ naloxone 0.15 mg/kg
Clonidine+ Saline	Clonidine	Clonidine 0.15 mg and saline 0.15 mg/kg
Placebo +Naloxone	placebo	Placebo 0.15 mg+ naloxone 0.15 mg/kg
Placebo +saline	placebo	Placebo 0.15 mg+ saline 0.15 mg/kg
Clonidine + Naloxone	Naloxone	Clonidine 0.15 mg and Naloxone 0.15 mg/kg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel