Mechanisms and Modulators of Placebo Analgesia in Healthy VolunteersNCT01886014
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
A study testing Oxytocin in people with Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers, male and female
- being German-speaking
- Agreeing to participate, verified by completion of informed consent
Who cannot join
- acute or chronic pain condition
- use of any concomitant medication except contraceptives
- currently pregnant (verified by urine pregnancy test) or lactating
- major mental disorder
- Inability to comply with the study procedures
- abnormal pain sensitivity as indicated by pain threshold
- alcohol intake within last 24 hours
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
Read the detailed description
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
The rationale to study the effects of oxytocin on placebo analgesia is based on previous studies showing that oxytocin fosters processes such as empathy, trust and social learning, which are key elements of the patient-physician relationship that is pivotal to placebo responses. In this experimental mechanisms study we used oxytocin as a tool to modulate these factors.
Placebo analgesia is induced verbal instruction. Therefore two identically looking placebo ointments were applied to two sites of the participants' volar forearm. The ointments were introduced as a local anesthetic that could reduce or even abolish pain (placebo) and a control cream (control), respectively.
- Being tested
- Oxytocin, placebo
- Keywords
- pain, pain modulation, placebo analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | application of intranasal oxytocin 40IE Receives: Drug: Oxytocin |
| placebo | Placebo comparator | application of intranasal saline
Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo analgesic responses
In this study the placebo analgesic response is defined as the difference in pain rating (visual analogue scale [0-100]) to thermal painful stimulation on the forearm on the placebo site compared to a control site.
Measured: ~ 45 min after appliction of oxytocin or saline
Secondary outcomes (1)
pain rating on the control site
VAS pain rating [0-100] in the control (non-placebo) condition.
Measured: ~45 min after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanisms and Modulators of Placebo Analgesia in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Bingel, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Ulrike Bingel, MD, PhD, Principal investigator, Department of Neurology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886014
- Sponsor's protocol ID
- placebo_oxy
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kessner S, Sprenger C, Wrobel N, Wiech K, Bingel U. Effect of oxytocin on placebo analgesia: a randomized study. JAMA. 2013 Oct 23;310(16):1733-5. doi: 10.1001/jama.2013.277446. No abstract available.
PubMed 24150470
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design
- ClinicalTrials.gov ID
- NCT01886014
- Acronym / sponsor ID
- placebo_oxy
- Keywords
- pain, pain modulation, placebo analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Jun 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.
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
Detailed description
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
The rationale to study the effects of oxytocin on placebo analgesia is based on previous studies showing that oxytocin fosters processes such as empathy, trust and social learning, which are key elements of the patient-physician relationship that is pivotal to placebo responses. In this experimental mechanisms study we used oxytocin as a tool to modulate these factors.
Placebo analgesia is induced verbal instruction. Therefore two identically looking placebo ointments were applied to two sites of the participants' volar forearm. The ointments were introduced as a local anesthetic that could reduce or even abolish pain (placebo) and a control cream (control), respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: Oxytocinapplication of intranasal oxytocin 40IE |
| placebo | Placebo comparator | Other: placeboapplication of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers, male and female
- being German-speaking
- Agreeing to participate, verified by completion of informed consent
Key exclusion criteria (7 listed)
- acute or chronic pain condition
- use of any concomitant medication except contraceptives
- currently pregnant (verified by urine pregnancy test) or lactating
- major mental disorder
- Inability to comply with the study procedures
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 |
|---|---|---|
| Oxytocin | Drug | oxytocin |
| placebo | Other | placebo |
Primary outcome
Placebo analgesic responses
Time frame: ~ 45 min after appliction of oxytocin or saline
In this study the placebo analgesic response is defined as the difference in pain rating (visual analogue scale [0-100]) to thermal painful stimulation on the forearm on the placebo site compared to a control site.
1 secondary outcome
pain rating on the control site
Time frame: ~45 min after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Derived from this study: PubMed 24150470Kessner S, Sprenger C, Wrobel N, Wiech K, Bingel U. Effect of oxytocin on placebo analgesia: a randomized study. JAMA. 2013 Oct 23;310(16):1733-5. doi: 10.1001/jama.2013.277446. No abstract available.
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.
Ulrike Bingel, MD, PhD principal investigator
Department of Neurology, University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 7 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: finished, as of the sponsor's last update on 26 Jun 2013. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Placebo analgesic responses (time frame: ~ 45 min after appliction of oxytocin or saline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886014, which also lists 1 linked publication.
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 26 Jun 2013.