Oxytocin and Arginine Vasopressin in Pain Relief
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Purpose
Background:
- Oxytocin, a substance produced mostly in the brain, plays a role in influencing social interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and reactions to stress, and may also be related to pain. Researchers are interested in investigating both substances and their relationship to pain in healthy volunteers.
Objectives:
- To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy volunteers.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
Design:
- This study involves two 2-hour testing sessions held 1 day apart. Each session includes the administration of oxytocin, arginine vasopressin, or placebo (a nonactive substance), or no drug. The drugs and the placebo will be given by a nasal spray.
- At the first visit, participants will provide blood and saliva samples to measure hormone levels, and will be asked to fill out questionnaires about some psychological factors such as anxiety and empathy. Participants will then have an assessment of their sensitivity to pain, consisting of a brief electrical stimulation that lasts less than 1 second. After the pain assessment, participants will receive oxytocin, arginine vasopressin, placebo, or no drug at all, and will be monitored to provide baseline information. Participants will then have another pain sensitivity test and will complete the questionnaires again, and provide another saliva sample.
- At the second visit, participants will provide another saliva sample; receive oxytocin, arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity and a pain-relieving procedure. During the pain-relieving procedure, participants will receive brief, moderately painful electrical shocks on the back of the nondominant hand and a low-level electrical stimulation on the middle finger that counteracts or reduces the pain from the shocks. Participants will rate their pain perception at the end of each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum imaginable pain). The experiment ends with a final saliva collection and completion of the psychological questionnaires....
| Condition |
|---|
|
Placebo Analgesia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Role of Oxytocin and Arginine Vasopressin in Human Placebo Analgesia |
| Estimated Enrollment: | 110 |
| Study Start Date: | March 2011 |
Objective: It has long been known that social and contextual cues and the whole atmosphere around the patient, such as words, attitudes, providers' behaviors, all contribute to evoke placebo responses. Moreover, an extensive literature investigating prosocial behaviors (e.g. ability to share the others' feelings, imitation, mimicry) suggests that social modeling is critical in developing learning processes across species, including social influences on psychophysical aspects of pain. Only recently, it has been demonstrated that observing the beneficial effects in the demonstrator induces substantial placebo analgesic responses which are positively correlated with empathy. A crucial role in social behaviors is played by oxytocin (OXT) and arginine vasopressin (AVP), two neuropeptides, produced mostly in the hypothalamus and acting on certain brain regions whose function is associated with emotion perception (amygdala and accumbens nucleus), eye-gaze, trust and processing of positive and negative social cues. As beliefs, trust and contextual cues are important elements of the clinician-patient relationship and socially-induced placebo effects, it is reasonable to hypothesize that OXT may be one of the endogenous substances that trigger contextual and interpersonal placebo responses. By seeing interpersonal healing as a central causal process (or a set of related causal processes) within the modulation of pain, it is worthy to probe the potential role for OXT and AVP in the modulation of a placebo response. In pursuit of this goal, we use a neuropharmacological intervention with OXT agonist and AVP in combination with a behavioral and genetic approach.
Study population: Healthy men and women participants aging from 18 to 55 years.
Design: We will investigate the role of oxytocinergic system in the processing of social cues by using a model of pain and interpersonal placebo analgesia already tested (9). The following drugs will be used: 1) oxytocin, 2) arginine vasopressin, and 3) placebo.
Outcome measures: Secondary measures include skin conductance response, heart rate, cortisol, subjective measures of empathy; trait and state anxiety measures; and functional pain-related genetic polymorphisms.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
Men and Women
Aged between 18-55 years
Able to understand and speak the English language
EXCLUSION CRITERIA:
Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurologic illness, seizures, etc.)
History of angioedema
High or low blood pressure (more than 140 mmHg or less than 60 mmHg)
History of fainting
A family history of mania, schizophrenia, or other psychoses
A history of mania, schizophrenia, or other psychoses
Any current Axis I psychiatric disorders
Lifetime alcohol/drug dependence
Alcohol/drug abuse in the past year
Current use of psychotropic medication
Impaired hearing
Pregnancy
Breast-feeding
Smokers (use of any form of nicotine during the last six months)
Contacts and Locations| Contact: Luana Colloca, M.D. | (301) 435-8715 | collocaln@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Luana Colloca, M.D. | National Center for Complementary and Alternative Medicine (NCCAM) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT01328561 History of Changes |
| Other Study ID Numbers: | 110104, 11-M-0104 |
| Study First Received: | April 1, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Arginine Oxytocin Vasopressin Placebo |
Analgesia Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Diabetes Insipidus Kidney Diseases Urologic Diseases Pituitary Diseases Endocrine System Diseases Arginine Vasopressin Vasopressins Oxytocin Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Oxytocics Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013