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The Relationships Between the Noradrenergic, Opioid and Pain System

NCT ID: NCT01851486

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Experimental Pain Perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Clonidine+ Saline

Clonidine 0.15 mg and saline 0.15 mg/kg

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

Clonidine 0.15 mg

saline

Intervention Type OTHER

Clonidine + Naloxone

Clonidine 0.15 mg and Naloxone 0.15 mg/kg

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

Clonidine 0.15 mg

Naloxone

Intervention Type DRUG

naloxone 0.15 mg/kg

Placebo +Naloxone

Placebo 0.15 mg+ naloxone 0.15 mg/kg

Group Type ACTIVE_COMPARATOR

Naloxone

Intervention Type DRUG

naloxone 0.15 mg/kg

placebo

Intervention Type DRUG

Placebo +saline

Placebo 0.15 mg+ saline 0.15 mg/kg

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

saline

Intervention Type OTHER

Interventions

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Clonidine

Clonidine 0.15 mg

Intervention Type DRUG

Naloxone

naloxone 0.15 mg/kg

Intervention Type DRUG

placebo

Intervention Type DRUG

saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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d_yarnitsky

Professor, Head on Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0393-12-RMB.CTIL

Identifier Type: -

Identifier Source: org_study_id