Trial · Interventional

CompletedPhase 1Registry data

Effects of Intranasal Oxytocin Administration on Social Influence Effects on Pain

NCTNCT03060031Other idGRANT11076934

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 51 participants (actual)
Sponsor: University of Colorado, Boulder · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 21 Jun 2017
Primary completion: 5 Mar 2019
Completion: 1 Apr 2019
First posted: 23 Feb 2017
Last update posted: 25 Jun 2019
Conditions: Pain

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020

Ph 1
Effects of Intranasal Oxytocin Administration on Social Influence Effects on Pain
NCT03060031
21 Jun 2017 to 1 Apr 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This experiment will explore the joint effects of social information, social support, associative learning, and oxytocin on the development of placebo analgesia. The investigators predict that socially transmitted placebo effects will be enhanced by nasal administration of oxytocin, whereas associative learning effects on pain will not be altered by this pharmacological manipulation

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Experimental
Oxytocin
Each participant will undergo pain tasks after self-administration of oxytocin
Placebo comparator
Placebo
Each participant will undergo pain tasks after self-administration of placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame · Measured during pain tasks at session 1 (within one month of screening survey completion) and 2 which will be within one week of each other.
Registry description
Self reported expectation of pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Change in pain rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame · Measured during pain tasks at session 1(within one month of screening survey completion) and 2 which will be within one week of each other.
Registry description
Self reported pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Change in pain unpleasantness rating score during hand holding and control conditions made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame · Measured during pain tasks at session 1 (within one month of screening survey completion)and 2 which will be within one week of each other.
Registry description
Self reported pain unpleasantness using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies18

Studies that cite this trial.

Studies with results

10 studies on this page

Indexing hint: Clinical trial · 2012

1 result

Oxytocin as a moderator of hypnotizability.

Bryant et al. 2012Psychoneuroendocrinologycited by 38

PMID 21652150DOI 10.1016/j.psyneuen.2011.05.010PUB-21652150

Full text at the publisher1 result

Publisher page See results (1)

Indexing hint: Systematic review · 2011

3 results

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

MacDonald et al. 2011Psychoneuroendocrinologycited by 276

PMID 21429671DOI 10.1016/j.psyneuen.2011.02.015PUB-21429671

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2010

2 results

Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders.

Guastella et al. 2010Biological psychiatrycited by 686

PMID 19897177DOI 10.1016/j.biopsych.2009.09.020PUB-19897177

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Randomized controlled trial · 2010

2 results

Acute effects of intranasal oxytocin on subjective and behavioral responses to social rejection.

Alvares et al. 2010Experimental and clinical psychopharmacologycited by 64

PMID 20695687DOI 10.1037/a0019719PUB-20695687

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Randomized controlled trial · 2009

6 results

A randomized controlled trial of intranasal oxytocin as an adjunct to exposure therapy for social anxiety disorder.

Guastella et al. 2009Psychoneuroendocrinologycited by 259

PMID 19246160DOI 10.1016/j.psyneuen.2009.01.005PUB-19246160

Full text at the publisher6 results

Publisher page See results (6)

Indexing hint: Randomized controlled trial · 2008

2 results

Oxytocin enhances the encoding of positive social memories in humans.

Guastella et al. 2008Biological psychiatrycited by 251

PMID 18343353DOI 10.1016/j.biopsych.2008.02.008PUB-18343353

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Randomized controlled trial · 2008

3 results

Effects of oxytocin and prosocial behavior on brain responses to direct and vicariously experienced pain.

Singer et al. 2008Emotion (Washington, D.C.)cited by 172

PMID 19102589PMC2672051DOI 10.1037/a0014195PUB-19102589

Rights unknown3 results

Source link See results (3)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin is associated with human trustworthiness.

Zak et al. 2005Hormones and behaviorcited by 224

PMID 16109416DOI 10.1016/j.yhbeh.2005.07.009PUB-16109416

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2003

4 results

Social support and oxytocin interact to suppress cortisol and subjective responses to psychosocial stress.

Heinrichs et al. 2003Biological psychiatrycited by 1,264

PMID 14675803DOI 10.1016/s0006-3223(03)00465-7PUB-14675803

Full text at the publisher4 results

Publisher page See results (4)

More studies

8 studies on this page

Indexing hint: Animal study · 2011

Oxytocin in the periaqueductal gray participates in pain modulation in the rat by influencing endogenous opiate peptides.

Yang et al. 2011Peptidescited by 47

PMID 21439337DOI 10.1016/j.peptides.2011.03.007PUB-21439337

Full text at the publisher

Publisher page

Indexing hint: Animal study · 2011

Oxytocin in the periaqueductal grey regulates nociception in the rat.

Yang et al. 2011Regulatory peptidescited by 35

PMID 21545817DOI 10.1016/j.regpep.2011.04.007PUB-21545817

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2010

Oxytocin selectively improves empathic accuracy.

Bartz et al. 2010Psychological sciencecited by 281

PMID 20855907PMC6634294DOI 10.1177/0956797610383439PUB-20855907

Rights unknown

Source link

PubMed tag: none · 2010

Effects of oxytocin on recollections of maternal care and closeness.

Bartz et al. 2010Proceedings of the National Academy of Sciences of the United States of Americacited by 165

PMID 21115834PMC3003037DOI 10.1073/pnas.1012669107PUB-21115834

Rights unknown

Source link

PubMed tag: none · 2009

Oxytocin and social perception: oxytocin increases perceived facial trustworthiness and attractiveness.

Theodoridou et al. 2009Hormones and behaviorcited by 213

PMID 19344725DOI 10.1016/j.yhbeh.2009.03.019PUB-19344725

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2008

Oxytocin selectively facilitates recognition of positive sex and relationship words.

Unkelbach et al. 2008Psychological sciencecited by 87

PMID 19076479DOI 10.1111/j.1467-9280.2008.02206.xPUB-19076479

Full text at the publisher

Publisher page

Indexing hint: Animal study · 2006

Role of kappa- and delta-opioid receptors in the antinociceptive effect of oxytocin in formalin-induced pain response in mice.

Kh et al. 2006Regulatory peptidescited by 36

PMID 16712978DOI 10.1016/j.regpep.2006.04.004PUB-16712978

Full text at the publisher

Publisher page

Indexing hint: Animal study · 2002

Blockade effect of mu and kappa opioid antagonists on the anti-nociception induced by intra-periaqueductal grey injection of oxytocin in rats.

Ge et al. 2002Brain researchcited by 68

PMID 11821014DOI 10.1016/s0006-8993(01)03346-7PUB-11821014

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subject is a volunteer between 18 and 40 years of age. * If female, subject is non-lactating, not pregnant, and using a reliable contraception method * Subject is able to read and speak English. * Subject is able and willing to provide written informed consent. * Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires. * Subject is in good health. * For participants to be eligible for all tasks of the study, the participant must have a romantic partner and be willing to bring the partner to the study session. Exclusion Criteria: * Tests positive on the 14 panel poly-substance urine drug screen for illicit substances (e.g., marijuana (THC), cocaine (COC), phencyclidine (PCP), amphetamine (AMP), ecstasy (MDMA), methamphetamine (Mamp), opiates (OPI), oxycodone (OXY), methadone (MTD), barbiturates (BAR), benzodiazepines (BZO), buprenorphine (BUP), tricyclic antidepressants (TCA), propoxyphene (PPX)) * Chronic Pain * Do not have the ability to tolerate heat pain applied to the forearm * Have temporary abnormal levels of pain * Have score of \> 19 using the Center for Disease and Epidemiology Depression Scale * Current treatment (e.g., medications or therapy) for psychiatric disorders, including mood, anxiety, substance abuse, Attention-deficit/hyperactivity disorder (ADHD), psychosis; Neurological disorders (e.g., taking dopamine agonists for Parkinson's); Cardiovascular disease or medication (e.g., taking ACE (angiotensin-converting-enzyme) inhibitors for cardiac remodeling) * Frequent smoking (\> 5 cigarettes / day); frequent alcohol use (\>14 drinks / week); frequent migraines (\> 5 / month on average) or a history of neurologic disease or neuropathic pain. * Any allergy to Oxytocin

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