Experimental Pain PerceptionNCT01851486
The Relationships Between the Noradrenergic, Opioid and Pain System
A study testing Clonidine, Naloxone and saline in people with Experimental Pain Perception, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Experimental Pain Perception
- What is being tested?
- Clonidine, Naloxone and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Age 18-40
- No chronic disease
Who cannot join
- Subjects who suffer from chronic pain / pain syndrome
- use of anti-depressant or anti-psychotic drugs
- suffering from cardiovascular disease
- breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Experimental Pain Perception
- Being tested
- Clonidine, Naloxone, placebo, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Clonidine 0.15 mg
NaloxoneDrug
naloxone 0.15 mg/kg
placeboDrug
salineOther
| Study group | Role | What they receive |
|---|---|---|
| Clonidine+ Saline | Active comparator | Clonidine 0.15 mg and saline 0.15 mg/kg Receives: Drug: Clonidine; Other: saline |
| Clonidine + Naloxone | Active comparator | Clonidine 0.15 mg and Naloxone 0.15 mg/kg Receives: Drug: Clonidine; Drug: Naloxone |
| Placebo +Naloxone | Active comparator | Placebo 0.15 mg+ naloxone 0.15 mg/kg Receives: Drug: Naloxone; Drug: placebo |
| Placebo +saline | Placebo comparator | Placebo 0.15 mg+ saline 0.15 mg/kg Receives: Drug: placebo; Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Labortory focus was changed and study was not opened at all
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental Pain PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d_yarnitsky, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851486
- Sponsor's protocol ID
- 0393-12-RMB.CTIL
- Status last verified
- Oct 2017
- First submitted
- 2 May 2013
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships Between the Noradrenergic, Opioid and Pain System
- ClinicalTrials.gov ID
- NCT01851486
- Acronym / sponsor ID
- 0393-12-RMB.CTIL
- Conditions
- Experimental Pain Perception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Labortory focus was changed and study was not opened at all
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clonidine+ Saline | Active comparator | Drug: Clonidine, Other: salineClonidine 0.15 mg and saline 0.15 mg/kg |
| Clonidine + Naloxone | Active comparator | Drug: Clonidine, Drug: NaloxoneClonidine 0.15 mg and Naloxone 0.15 mg/kg |
| Placebo +Naloxone | Active comparator | Drug: Naloxone, Drug: placeboPlacebo 0.15 mg+ naloxone 0.15 mg/kg |
| Placebo +saline | Placebo comparator | Drug: placebo, Other: salinePlacebo 0.15 mg+ saline 0.15 mg/kg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age 18-40
- No chronic disease
Key exclusion criteria (4 listed)
- Subjects who suffer from chronic pain / pain syndrome
- use of anti-depressant or anti-psychotic drugs
- suffering from cardiovascular disease
- breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonidineClonidine 0.15 mg | Drug | Clonidine + Naloxone, Clonidine+ Saline |
| Naloxonenaloxone 0.15 mg/kg | Drug | Clonidine + Naloxone, Placebo +Naloxone |
| placebo | Drug | Placebo +Naloxone, Placebo +saline |
| saline | Other | Clonidine+ Saline, Placebo +saline |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
Related trials for Experimental Pain Perception
Recruiting
Tonic Pain and Transauricular Vagal Nerve Stimulation
Experimental Pain in Healthy Human Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clonidine, Naloxone and saline in people with Experimental Pain Perception, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.