Oxytocin for Ehlers-Danlos Syndrome
(EDS-OXY Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: Hormonal contraceptives
Disqualifiers: Pregnancy, Lactation, Autoimmune disorders, others
Trial Summary
What is the purpose of this trial?This trial is testing if a treatment can help reduce long-term pain in women with a specific condition. The treatment might work by influencing how the body processes pain and emotions. It has been increasingly investigated for its potential in pain relief, with initial studies focusing on its effects during labor and breastfeeding.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable regimen for pain control, meaning you should not change your current pain medications during the study.
What data supports the effectiveness of the drug oxytocin for treating Ehlers-Danlos Syndrome?
Research suggests that oxytocin may help manage pain, as it has been studied for its potential to reduce pain perception in conditions like chronic pain and fibromyalgia. However, results are mixed, and in some cases, oxytocin did not show positive effects, indicating that its effectiveness can vary.
12345How does the drug oxytocin differ from other treatments for Ehlers-Danlos Syndrome?
Oxytocin is unique because it is a naturally occurring hormone that is being explored for its potential pain-relieving properties, which could be beneficial for managing chronic pain associated with Ehlers-Danlos Syndrome. Unlike traditional pain medications, oxytocin is non-addictive and has few adverse side effects, making it a novel option for pain management.
26789Eligibility Criteria
This trial is for premenopausal females over 18 with hypermobile Ehlers-Danlos syndrome who experience chronic pain in multiple joints. Participants must have a stable pain management regimen and agree to use non-hormonal contraception. Excluded are those with certain heart conditions, autoimmune disorders causing joint inflammation, pregnancy, lactation, or allergies to oxytocin.Inclusion Criteria
I am a woman over 18 and have not gone through menopause.
I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
+4 more
Exclusion Criteria
I have a history of heart rhythm problems, except for harmless fast or slow beats.
Your heart beats too fast or too slow, even when resting.
I have been diagnosed with an autoimmune disorder that causes joint pain.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Period 1
Participants receive either placebo or oxytocin infusion over three consecutive days, with daily subjective pain evaluation and monitoring using ACTIHEART device.
3 weeks
3 visits (in-person)
Washout Period
A one-month period between the two treatment phases to eliminate the effects of the first treatment.
4 weeks
Treatment Period 2
Participants receive the alternate treatment (placebo or oxytocin) over three consecutive days, with daily subjective pain evaluation and monitoring using ACTIHEART device.
3 weeks
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of anxiety, depression, and pain levels.
2 weeks
Participant Groups
The study tests the effect of intravenous oxytocin on chronic pain against a placebo in patients with Hypermobile Ehlers-Danlos Syndrome (hEDS). It's designed to see if oxytocin can reduce their pain levels more effectively than a placebo.
2Treatment groups
Active Control
Placebo Group
Group I: OxytocinActive Control1 Intervention
Treatment infusion: IV 1IU Oxytocin in 200ml of 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Group II: PlaceboPlacebo Group1 Intervention
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
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:
Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
References
Effects of intranasal oxytocin on pain perception among human subjects: A systematic literature review and meta-analysis. [2023]Oxytocin (OXT) is a peptide hormone produced in the hypothalamus that plays a neuromodulatory role in emotion, stress, and anxiety. Due to its multidimensional role, OXT is a promising target for therapeutic interventions to treat pain.
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.
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.
Oxytocin nasal spray in fibromyalgic patients. [2021]Fibromyalgia is a pain disorder associated with frequent comorbid mood, anxiety, and sleep disorders. Despite the frequent use of a complex, poly-drug pharmacotherapy, treatment for fibromyalgia is of limited efficacy. Oxytocin has been reported to reduce the severity of pain, anxiety, and depression, and improve the quality of sleep, suggesting that it may be useful to treat fibromyalgia. To evaluate this hypothesis, 14 women affected by fibromyalgia and comorbid disorders, assuming a complex pharmacotherapy, were enrolled in a double-blind, crossover, randomized trial to receive oxytocin and placebo nasal spray daily for 3 weeks for each treatment. Order of treatment (placebo-oxytocin or oxytocin-placebo) was randomly assigned. Patients were visited once a week. At each visit, the following instruments were administered: an adverse drug reaction record card, Visual Analog Scale of Pain Intensity, Spielberger State Anxiety Inventory, Zung Self-rating Depression Scale, and SF-12. Women self-registered painkiller assumption, pain severity, and quality of sleep in a diary. Unlikely, oxytocin nasal spray (80 IU a day) did not induce positive therapeutic effects but resulted to be safe, devoid of toxicity, and easy to handle.
Sex-specific effects of intranasal oxytocin on thermal pain perception: A randomised, double-blind, placebo-controlled cross-over study. [2018]Chronic neck and shoulder pain (CNSP) is a common musculoskeletal disorder in adults, which is linked to hypersensitivity to noxious stimuli. The hormone oxytocin has been implicated as a potential therapeutic for the management of chronic pain disorders, and has been suggested to have sex-specific effects on the salience of threatening stimuli. This study investigated the influence of intranasal oxytocin on the perception of noxious thermal stimuli. Participants were 24 individuals with CNSP lasting >12months (eight women), and 24 age- and sex-matched healthy, pain-free controls. In a randomised double-blind, placebo-controlled, cross-over study, participants attended two sessions, self-administering intranasal oxytocin (24 IU) in one session, and placebo in another. Participants rated intensity and unpleasantness of thermal heat stimuli at three body sites: the cervical spine, deltoid, and tibialis anterior, on 11-point numerical rating scales. Compared with placebo, intranasal oxytocin increased the perceived intensity of noxious heat stimuli in women with CNSP (Cohen's d=0.71), but not in men with CNSP, or healthy, pain-free controls. Men and women displayed divergent sensitivity across target sites for ratings of pain intensity (partial eta squared=0.12) and pain unpleasantness (partial eta squared=0.24), irrespective of drug condition. Men were more sensitive at the cervical spine and deltoid, whereas women were more sensitive at the tibialis. These findings suggest that oxytocin and endogenous sex hormones may interact to influence the salience of noxious stimuli. The hyperalgesic effects of oxytocin in women suggest that caution should be taken when considering oxytocin in the management of chronic pain.
A new approach to the hormonal treatment of impotentia erectionis. [2009]The influence of oraly administered synthetic oxytocin (Syntocinon, Sandoz) on the impotentia erectionis has been studied in a double-blind trial in comparison to placebo. Twenty-nine out-patients divided into 3 groups were treated for a minimum of 7 weeks. Nine patients were given 300 IU daily, ten patients 600 IU daily and further 10 patients placebo. The treatment with 300 IU of oxytocin daily has shown the best therapeutic results. The difference between this group and the placebo group was statistically significant regarding the overall parameters sexual interest and sexual capability (P less than 0.05) and P less than 0.10 respectively). The daily oral dose of 600 IU produced no significant therapeutic effect. Oxytocin in both dosage schedules was well tolerated and no untoward side effects were observed.
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Anaphylactoid reaction to oxytocin in pregnancy. [2019]A case of an allergic reaction to Syntocinon (synthetic oxytocin) administered during Caesarean section is reported.