Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrike Bingel, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01886014
First received: June 20, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
Drug: Oxytocin
Other: placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin
application of intranasal oxytocin 40IE
Drug: Oxytocin
Placebo Comparator: placebo

application of intranasal saline

Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.

Other: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886014

Locations
Germany
Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Ulrike Bingel, MD, PhD Department of Neurology, University Medical Center Hamburg-Eppendorf
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrike Bingel, PD Dr. Ulrike Bingel, attending of neurology, research group leader, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01886014     History of Changes
Other Study ID Numbers: placebo_oxy
Study First Received: June 20, 2013
Last Updated: June 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
pain
pain modulation
placebo analgesia

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014