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

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.

Study Overview

• Status: Completed
• Conditions: Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
• Intervention / Treatment: Other: placebo; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Neurology, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oxytocin; application of intranasal oxytocin 40IE	Drug: Oxytocin
Placebo Comparator: placebo; application of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	~ 45 min after appliction of oxytocin or saline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain rating on the control site	VAS pain rating [0-100] in the control (non-placebo) condition.	~45 min after application

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Ulrike Bingel, MD, PhD, Department of Neurology, University Medical Center Hamburg-Eppendorf

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: pain; pain modulation; placebo analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: placebo_oxy