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

NCT ID: NCT01886014

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

oxytocin

application of intranasal oxytocin 40IE

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

placebo

application of intranasal saline

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

Oxytocin

Intervention Type: DRUG

placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Ulrike Bingel

PD Dr. Ulrike Bingel, attending of neurology, research group leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrike Bingel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Medical Center Hamburg-Eppendorf

Locations

Department of Neurology, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 24150470 (View on PubMed)

Other Identifiers

placebo_oxy

Identifier Type: -

Identifier Source: org_study_id