Overseen ByJames C Eisenach, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wake Forest University Health Sciences
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.
Will I have to stop taking my current medications?
The trial requires that participants do not take benzodiazepines or pain medications daily. If you are on these medications, you would need to stop taking them to participate.
How is the drug oxytocin unique in treating chronic pain?
Oxytocin is unique in treating chronic pain because it is a naturally occurring hormone that may modulate pain by affecting both the central and peripheral nervous systems, offering a non-addictive alternative to traditional pain medications like opioids. It is administered intranasally, which is different from many other pain treatments, and it has shown potential to reduce pain sensitivity without the serious side effects associated with other pain relief drugs.
12389Is intranasal oxytocin safe for humans?
Intranasal oxytocin is generally well tolerated in humans, with common side effects including nasal discomfort, tiredness, irritability, diarrhea, and skin irritation. Severe side effects are rare, and studies suggest it is safe for use in conditions like autism spectrum disorder.
467910What evidence supports the effectiveness of the drug oxytocin for chronic pain?
Research suggests that oxytocin, a naturally occurring hormone, may help reduce pain by affecting how the body processes pain signals. Some studies have shown that oxytocin can enhance the effects of placebos (inactive treatments) and may have potential as a new way to manage chronic pain, but more research is needed to confirm its benefits.
15789Eligibility Criteria
This trial is for adults aged 18-75 with good health, normal blood pressure or controlled hypertension, and a BMI under 40. It's open to both healthy volunteers and those with knee arthritis. Women of childbearing age must use effective birth control. People can't join if they have certain health risks, are pregnant/nursing/recently pregnant, suffer from chronic pain or diabetes, take daily benzodiazepines/pain meds, or have specific eye conditions.Inclusion Criteria
My blood pressure and heart rate are within the normal range without medication.
I am between 18 and 75 years old with a BMI under 40.
My blood pressure is normal or controlled, and my heart rate is between 45-100 bpm.
Exclusion Criteria
I have eye conditions or have had eye surgery that affects my vision or causes tremors.
Participant Groups
The study tests the impact of oxytocin (a hormone) given by muscle injection on the 'rest and digest' nervous system activity through pupil response in people with chronic pain/osteoarthritis versus a placebo.
2Treatment groups
Experimental Treatment
Group I: Placebo, Then OxytocinExperimental Treatment2 Interventions
Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection
Group II: Oxytocin First, then PlaceboExperimental Treatment2 Interventions
Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇪🇺 Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇨🇦 Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Wake Forest Baptist HealthWinston-Salem, NC
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
References
Oxytocin and the modulation of pain experience: Implications for chronic pain management. [2015]In an acute environment pain has potential protective benefits. However when pain becomes chronic this protective effect is lost and the pain becomes an encumbrance. Previously unheralded substances are being investigated in an attempt to alleviate the burden of living with chronic pain. Oxytocin, a neuropeptide hormone, is one prospective pharmacotherapeutic agent gaining popularity. Oxytocin has the potential to modulate the pain experience due to its ubiquitous involvement in central and peripheral psychological and physiological processes, and thus offers promise as a therapeutic agent. In this review, we discuss previous effective applications of oxytocin in pain-free clinical populations and its potential use in the modulation of pain experience. We also address the slowly growing body of literature investigating the administration of oxytocin in clinical and experimentally induced pain in order to investigate the potential mechanisms of its reported analgesic actions. We conclude that oxytocin offers a potential novel avenue for modulating the experience of pain, and that further research into this area is required to map its therapeutic benefit.
The analgesic effects of oxytocin in the peripheral and central nervous system. [2022]Pain is a ubiquitously unpleasant feeling among humans as well as many animal species often caused by actual and potential tissue damage. However, it is absolutely crucial for our survival in many ways. Acute pain can signal the presence of danger or life-threatenting events, which help escape noxious stimuli. By contrast, when pain becomes chronic or persistent, it becomes an encumbrance and exerts deleterious effects to the body and mind, often co-occured with anxiety and depression. Additionaly, chronic pain is more or less an economic burden for the patients because it requires immediate medical treatments and seriously hinders pepople in their work. To date, there has been a lack of breakthrough progress in the pain field, despite huge gains in basic science knowledge obtained using animal models, it is still difficult to develop many new clinically effective analgesic drugs to control pain with long-term effectiveness. Opioids and nonsteroidal anti-inflammatory drugs were introduced for pain management more than a century ago. Those drugs do have proven efficacy in the treatment of pain but the use of them are also significantly limited due to the multiple serious adverse effects (e.g., drug resistance, addiction and gastrointestinal bleeding). In the field of pain relief and treatment, there is a strong impetus to develop and establish novel analgesics that must be safer and more effective to offer significant pain relief for a wide variety of painful conditions. Preliminary evidence suggests that oxytocin might be the ideal candidate as a target for reducing the severity of pain. In this review, we present a summary of the total literature related to the effects of oxytocin on pain modulation in both animals and humans. Better understanding the fundamental physiopharmacology of the actions of oxytocin in pain may highlight novel mechanisms associated with analgesia.
Protocol for a placebo-controlled, within-participants crossover trial evaluating the efficacy of intranasal oxytocin to improve pain and function among women with chronic pelvic musculoskeletal pain. [2022]This protocol presents the rationale and design for a trial evaluating the efficacy of intranasal oxytocin in improving pain and function among women with chronic pelvic musculoskeletal pain. Oxytocin is a neuropeptide traditionally recognised for involvement in labour, delivery and lactation. Novel evidence suggests that oxytocin decreases pain sensitivity in humans. While oxytocin administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation and colon pain, no research has evaluated the association between intranasal oxytocin and chronic pelvic musculoskeletal pain. The association between oxytocin and pain may differ in women with chronic pelvic musculoskeletal pain relative to other chronic pain conditions because of the abundance of oxytocin receptors in the uterus.
Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. [2018]Recent studies have suggested oxytocin as a possible drug to treat social deficits caused by autism spectrum disorder (ASD), but the safety of intranasal oxytocin in autistic patients has not been established. The aim of this review was to characterize the side-effect profile of long-term intranasal oxytocin in treatment of ASD compared to placebo. All randomized controlled trials of intranasal oxytocin in the treatment of ASD published before 1 January 2017 that reported safety data were identified from databases, including PubMed, Embase, Cochrane Library, and International Pharmaceutical Abstract. Relevant data from the selected studies were then extracted for meta-analysis to estimate the pooled risk ratio for the most common adverse events. Descriptive analysis of severe adverse events was also conducted. Of the 223 participants in the five included studies, 123 were given oxytocin and 100 were given placebos. Nasal discomfort (14.3%), tiredness (7.2%), irritability (9.0%), diarrhea (4.5%), and skin irritation (4.5%) were the most common adverse events. None of these common adverse events was statistically associated with treatment allocation according to meta-analysis using pooled data (all P-values > 0.1). Five severe adverse events were reported, namely aggression (one in placebo, two in oxytocin) and seizures (one in placebo, one in oxytocin). Results from this systematic review support intranasal oxytocin as well tolerated and safe for use in the ASD population. Larger clinical trials should be conducted to establish the efficacy of intranasal oxytocin as a treatment of ASD.
Enhancing Placebo Effects in Somatic Symptoms Through Oxytocin. [2019]Placebo effects relieve various somatic symptoms, but it is unclear how they can be enhanced to maximize positive treatment outcomes. Oxytocin administration may potentially enhance placebo effects, but few studies have been performed, and they have had conflicting findings. The study aim was to investigate the influence of positive verbal suggestions and oxytocin on treatment expectations and placebo effects for pain and itch.
A Nonpeptide Oxytocin Receptor Agonist for a Durable Relief of Inflammatory Pain. [2023]Oxytocin possesses several physiological and social functions, among which an important analgesic effect. For this purpose, oxytocin binds mainly to its unique receptor, both in the central nervous system and in the peripheral nociceptive terminal axon in the skin. However, despite its interesting analgesic properties and its current use in clinics to facilitate labor, oxytocin is not used in pain treatment. Indeed, it is rapidly metabolized, with a half-life in the blood circulation estimated at five minutes and in cerebrospinal fluid around twenty minutes in humans and rats. Moreover, oxytocin itself suffers from several additional drawbacks: a lack of specificity, an extremely poor oral absorption and distribution, and finally, a lack of patentability. Recently, a first non-peptide full agonist of oxytocin receptor (LIT-001) of low molecular weight has been synthesized with reported beneficial effect for social interactions after peripheral administration. In the present study, we report that a single intraperitoneal administration of LIT-001 in a rat model induces a long-lasting reduction in inflammatory pain-induced hyperalgesia symptoms, paving the way to an original drug development strategy for pain treatment.
Intranasal oxytocin as a treatment for chronic pelvic pain: A randomized controlled feasibility study. [2021]To investigate the effect of intranasal oxytocin on chronic pelvic pain in a randomized, double-blind, within-subject crossover trial. Aims included: (1) determine intranasal oxytocin's effect on pain intensity and pain interference relative to placebo; (2) assess feasibility and acceptability.
Anti-nociceptive effects of oxytocin receptor modulation in healthy volunteers-A randomized, double-blinded, placebo-controlled study. [2021]There is increasing evidence for oxytocin as a neurotransmitter in spinal nociceptive processes. Hypothalamic oxytocinergic neurons project to the spinal dorsal horn, where they activate GABA-ergic inhibitory interneurons. The present study tested whether the long-acting oxytocin-analogue carbetocin has anti-nociceptive effects in multi-modal experimental pain in humans.
Evaluating the efficacy of intranasal oxytocin on pain and function among individuals who experience chronic pain: a protocol for a multisite, placebo-controlled, blinded, sequential, within-subjects crossover trial. [2022]Current treatments for chronic pain (eg, opioids) can have adverse side effects and rarely result in resolution of pain. As such, there is a need for adjuvant analgesics that are non-addictive, have few adverse side effects and are effective for pain management across several chronic pain conditions. Oxytocin is a naturally occurring hormone that has gained attention for its potential analgesic properties. The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.
Structure-Based Design of Glycosylated Oxytocin Analogues with Improved Selectivity and Antinociceptive Activity. [2023]Acute and chronic pain is often treated with opioids despite the negative side effects of constipation, physical dependence, respiratory depression, and overdose. The misuse of opioid analgesics has given rise to the opioid crisis/epidemic, and alternate nonaddictive analgesics are urgently needed. Oxytocin, a pituitary hormone, is an alternative to the small molecule treatments available and has been used as an analgesic as well as for the treatment and prevention of opioid use disorder (OUD). Clinical implementation is limited by its poor pharmacokinetic profile, a result of the labile disulfide bond between two cysteine residues in the native sequence. Stable brain penetrant oxytocin analogues have been synthesized by replacement of the disulfide bond with a stable lactam and glycosidation of the C-terminus. These analogues show exquisite selectivity for the oxytocin receptor and potent in vivo antinociception in mice following peripheral (i.v.) administration, supporting further study of their clinical potential.