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

U

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers

Treatments

Other: placebo
Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT01886014
placebo_oxy

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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