The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design|
- Placebo analgesic responses [ Time Frame: ~ 45 min after appliction of oxytocin or saline ] [ Designated as safety issue: No ]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.
- pain rating on the control site [ Time Frame: ~45 min after application ] [ Designated as safety issue: No ]VAS pain rating [0-100] in the control (non-placebo) condition.
|Study Start Date:||January 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
application of intranasal oxytocin 40IE
Placebo Comparator: placebo
application of intranasal saline
Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886014
|Department of Neurology, University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Ulrike Bingel, MD, PhD||Department of Neurology, University Medical Center Hamburg-Eppendorf|