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

Not Applicable

Completed

• Conditions: Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
• Interventions: Other: placebo; Drug: Oxytocin

• Registration Number: NCT01886014
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-06
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	application of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.
oxytocin	Oxytocin	application of intranasal oxytocin 40IE

Primary Outcome Measures

Name	Time	Method
Placebo analgesic responses	~ 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 Outcome Measures

Name	Time	Method
pain rating on the control site	~45 min after application	VAS pain rating \[0-100\] in the control (non-placebo) condition.

Trial Locations

Locations (1)

Department of Neurology, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany