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OpenTrials
Completed

NCT Number: NCT01886014

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Placebo

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. pain rating on the control site

    Time frame: ~45 min after application

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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 25, 2013
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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