The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 20, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedJune 26, 2013
June 1, 2013
8 months
June 20, 2013
June 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placebo analgesic responses
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.
~ 45 min after appliction of oxytocin or saline
Secondary Outcomes (1)
pain rating on the control site
~45 min after application
Study Arms (2)
oxytocin
EXPERIMENTALapplication of intranasal oxytocin 40IE
placebo
PLACEBO COMPARATORapplication of intranasal saline Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteers, male and female
- being German-speaking
- Agreeing to participate, verified by completion of informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Related Publications (1)
Kessner S, Sprenger C, Wrobel N, Wiech K, Bingel U. Effect of oxytocin on placebo analgesia: a randomized study. JAMA. 2013 Oct 23;310(16):1733-5. doi: 10.1001/jama.2013.277446. No abstract available.
PMID: 24150470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrike Bingel, MD, PhD
Department of Neurology, University Medical Center Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Ulrike Bingel, attending of neurology, research group leader
Study Record Dates
First Submitted
June 20, 2013
First Posted
June 25, 2013
Study Start
January 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 26, 2013
Record last verified: 2013-06