Skip to content

Oxytocin and placebo/nocebo effect

The role of oxytocin on placebo/nocebo effects in a pain conditioning paradigm

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25836
Enrollment
80
Registered
2017-06-08
Start date
2017-03-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placebo effect in healthy subjects

Interventions

A randomized, placebo-controlled study design will be used. After an initial screening, participants will take part in one study visit. First, participants will be randomly allocated to one of two gro
participants in the control group will receive the same volume of a placebo spray. Then three levels of heat stimulation will be determined for each participant individually which will be used in the
low pain), temperature that elicits mild to moderate levels of pain (equal to around 4 on the 10 NRS, mild pain) and temperature that elicits moderate to high but bearable levels of pain (equal to aro
moderate pain). Pain stimuli will be applied to the dorsal site of the left arm with an ATS thermode (ATS-II, Medoc Advanced Medical Systems, Ramat Yishai, Israel) with a peak temperature lasting for

Sponsors

Leiden University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteers between 18 and 35 years old; 2. Good understanding of written and spoken English.

Exclusion criteria

Exclusion criteria: 1. Current psychiatric (DSM-IV) conditions; 2. All conditions that might interfere with the participant's safety and/or the study protocol: e.g., severe somatic or psychological morbidity (e.g., heart and lung diseases, low blood pressure, family history of an acute heart failure or a death due to an acute heart failure, DSM-IV psychiatric disorders, and current use of analgesics drugs)

Design outcomes

Primary

MeasureTime frame
To investigate whether exogenous oxytocin administration enhances the placebo effect, the oxytocin and control groups will be compared on the difference between subjective pain ratings between the yellow (control) and green (placebo) cues in the heat pain conditioning task in the first part of the testing phase.

Secondary

MeasureTime frame
To investigate the effects of exogenous oxytocin administration on nocebo effect, the oxytocin and control groups will be compared on the difference between subjective pain ratings between the red (nocebo) and yellow (control) cues in the heat pain conditioning task in the first part of the testing phase.

Contacts

Public ContactA.W.M. Evers

LUMC PO Box 9555

a.evers@fsw.leidenuniv.nl+31 (0)71 527 3627

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)