Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
Conditions
Keywords
pain, pain modulation, placebo analgesia
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.
Interventions
DRUGOxytocin
OTHERplacebo
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| pain rating on the control site | ~45 min after application | VAS pain rating \[0-100\] in the control (non-placebo) condition. |
Countries
Germany
Outcome results
None listed