CompletedPhase 1

Effects of Intranasal Oxytocin Administration on Social Influence Effects on Pain

United States51 participantsStarted 2017-06-21

Plain-language summary

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

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 medicatio…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo

Timeframe: 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.

Change in pain rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo

Timeframe: 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.

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

Timeframe: 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.

Trial details

NCT IDNCT03060031

SponsorUniversity of Colorado, Boulder

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-05

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