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The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers

Primary Purpose

Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxytocin
placebo
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers focused on measuring pain, pain modulation, placebo analgesia

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers, male and female
  • being German-speaking
  • Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Neurology, University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxytocin

placebo

Arm Description

application of intranasal oxytocin 40IE

application of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pain rating on the control site
VAS pain rating [0-100] in the control (non-placebo) condition.

Full Information

First Posted
June 20, 2013
Last Updated
June 25, 2013
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01886014
Brief Title
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
Official Title
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
Keywords
pain, pain modulation, placebo analgesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Experimental
Arm Description
application of intranasal oxytocin 40IE
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
application of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Placebo analgesic responses
Description
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.
Time Frame
~ 45 min after appliction of oxytocin or saline
Secondary Outcome Measure Information:
Title
pain rating on the control site
Description
VAS pain rating [0-100] in the control (non-placebo) condition.
Time Frame
~45 min after application

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers, male and female being German-speaking Agreeing to participate, verified by completion of informed consent Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Bingel, MD, PhD
Organizational Affiliation
Department of Neurology, University Medical Center Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24150470
Citation
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.
Results Reference
derived

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The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers

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