CClinicalTrials.gg
WithdrawnNCT01851486Updated Oct 4, 2017

The Relationships Between the Noradrenergic, Opioid and Pain System

An interventional study of Clonidine and Naloxone in Experimental Pain Perception, sponsored by Rambam Health Care Campus. Withdrawn at 1 site in Israel. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-04.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Basic science

Why this study was withdrawn
Labortory focus was changed and study was not opened at all

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2013, registered May 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Experimental Pain Perception
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers
  • Age 18-40
  • No chronic disease

Exclusion criteria

Exclusion Criteria:

  • Subjects who suffer from chronic pain / pain syndrome
  • use of anti-depressant or anti-psychotic drugs
  • suffering from cardiovascular disease
  • breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Clonidine+ Saline

    Clonidine 0.15 mg and saline 0.15 mg/kg

    Drug: Clonidine · Other: saline

  • Active comparator
    Clonidine + Naloxone

    Clonidine 0.15 mg and Naloxone 0.15 mg/kg

    Drug: Clonidine · Drug: Naloxone

  • Active comparator
    Placebo +Naloxone

    Placebo 0.15 mg+ naloxone 0.15 mg/kg

    Drug: Naloxone · Drug: placebo

  • Placebo comparator
    Placebo +saline

    Placebo 0.15 mg+ saline 0.15 mg/kg

    Drug: placebo · Other: saline

Interventions

  • DrugClonidine

    Clonidine 0.15 mg

  • DrugNaloxone

    naloxone 0.15 mg/kg

  • Drugplacebo
  • Othersaline
06

What researchers measure

Primary outcomes

  1. The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist

    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

    Time frame: 2 years

07

Study locations

1 site
  • Rambam Health Care Campus
    Haifa, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01851486
Lead sponsor
Rambam Health Care Campus
Responsible party
d_yarnitsky (Professor, Head on Neurology Department, Rambam Health Care Campus) — Principal investigator
First posted
May 10, 2013
Start date
Jan 2013
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Oct 4, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion