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Oxytocin and placebo/nocebo effect


- candidate number27361
- NTR NumberNTR6506
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2017
- Secondary IDsP16.319 METC LUMC
- Public TitleOxytocin and placebo/nocebo effect
- Scientific TitleThe role of oxytocin on placebo/nocebo effects in a pain conditioning paradigm
- ACRONYMOxytocin and placebo/nocebo effect
- hypothesisThe primary objective is to investigate whether exogenous oxytocin administration enhances the placebo effect of classical conditioning and verbal suggestions as measured by subjective pain intensity to a previously validated heat pain conditioning task. We hypothesize that oxytocin will enhance the placebo effect as induced by positive verbal suggestions and conditioning procedure. In addition, we will explore the effects of oxytocin on the nocebo effect.
- Healt Condition(s) or Problem(s) studiedOxytocin, Placebo effect
- Inclusion criteria1. Healthy male volunteers between 18 and 35 years old;
2. Good understanding of written and spoken English.
- Exclusion criteria1. 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)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-mrt-2017
- planned closingdate1-dec-2017
- Target number of participants80
- InterventionsA 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 groups: 1) oxytocin group or 2) control group. Participants in the oxytocin group will receive 40 IU of intranasal oxytocin spray; 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 pain conditioning task: 1) a temperature that elicits low pain (equal to around 1 on the 10 numeric rating scale (NRS); 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 around 7 on the 10 NRS; 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 4 seconds. Subsequently, 30 minutes after the spray administration, when the oxytocin effects are assumed to be peaking (MacDonald & MacDonald, 2010), the heat pain conditioning task will be performed. This task consists of two phases: a learning phase and a testing phase. In the learning phase, a green light will be coupled to a low pain stimulus (placebo condition), a yellow light to a mild pain (control condition) and a red light to a moderate painful stimulus (nocebo condition). In addition, a sham electrode will be attached to the hands of participants and they will be told that the green light activates a mode of the electrode that has an analgesic effect and the red light will indicate the activation of the mode of the electrode that increases pain. In the test phase, only mild pain will be given while learned associations to coloured lights will be tested. After each pain stimulus, participants will be asked to rate the pain intensity on a 0 (no pain) - 10 (most intense pain imaginable) NRS.
The experiment will be concluded with filling out several questionnaires and participants will be debriefed and provided a chance to ask questions about the experiment and their participation.
- Primary outcomeTo 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 outcomeTo 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.
- TimepointsThe study consists of one session in which the heat pain conditioning task is performed once.
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.W.M. Evers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.W.M. Evers
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
European Research Council Consolidator Grant
- Publications
- Brief summaryPlacebo and nocebo effects have been repeatedly shown to be able to respectively relief or worsen symptoms of a variety of diseases such as pain, depression, anxiety, addiction, and Parkinsonís disease amongst others (Benedetti, 2008; Benedetti et al., 2003, Wolkov et al., 2003). Despite an increasing body of literature on placebo effects, it is currently not yet clear how we can maximize placebo effects in order to obtain the best therapeutic results and how to weaken the nocebo effects to reduce the side effects of medications. Oxytocin administration may potentially enhance the placebo effect by reducing anxiety, increasing trust and stimulating the secretion of nitric oxide that has been shown to mediate the placebo response. Only few studies have been performed in this important area with conflicting evidence. The primary objective of the current study is to investigate whether exogenous oxytocin administration enhances the placebo effect of classical conditioning and verbal suggestions as measured by subjective pain intensity to a previously validated heat pain conditioning task. In addition, the effects of oxytocin on nocebo effect will be explored.
- Main changes (audit trail)
- RECORD8-jun-2017 - 11-jul-2017


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