45 Participants Needed

Oxytocin + Oxycodone for Pain

JS
LN
Overseen ByLauren Nieder
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have any significant physical diseases or major psychiatric disorders, which might imply some restrictions on medications. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the drug combination of oxytocin and oxycodone for pain management?

Research shows that oxycodone, when combined with acetaminophen, is effective for managing moderate-to-severe pain due to their complementary actions, which may suggest potential benefits when combined with other agents like oxytocin. Additionally, oxycodone alone has been effective in reducing pain in various settings, including postoperative and cancer-related pain.12345

Is the combination of oxytocin and oxycodone generally safe for humans?

Oxycodone has been studied for safety in various conditions, showing it can be used safely for pain relief, but it may cause side effects like constipation and vomiting. There is no specific safety data available for the combination of oxytocin and oxycodone.16789

What makes the drug oxytocin + oxycodone unique for pain management?

This drug combination is unique because it combines oxycodone, a common opioid pain reliever, with oxytocin, a hormone that has potential analgesic (pain-relieving) properties and may offer pain relief with fewer side effects. Oxytocin's role in pain management is being explored for its non-addictive nature and ability to modulate pain through different mechanisms than traditional opioids.1011121314

Research Team

MB

Meredith S Berry, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for English-speaking individuals who occasionally use opioids recreationally, have normal blood pressure and heart rate, a clean EKG, are within 20% of ideal body weight, and don't suffer from chronic pain. Pregnant or nursing women, those with significant diseases or metal implants that affect MRI safety, or people seeking drug abuse treatment cannot participate.

Inclusion Criteria

I have not had chronic pain in the last 3 months.
My heart's electrical activity is normal and my blood tests show no major health issues.
Have a systolic blood pressure of <=140 and diastolic blood pressure of <= 90, and a heart rate <= 90 beats per minute.
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Exclusion Criteria

You are not currently seeking treatment for drug abuse.
You have a problem with using illegal drugs or are currently experiencing withdrawal symptoms from any abused drug (excluding nicotine and caffeine).
Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive oxycodone and oxytocin (combined and separately) across 6 sessions to evaluate effects on pain and abuse liability

6 weeks
6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • oxycodone
  • oxytocin
Trial OverviewThe study examines if combining oxytocin nasal spray with oxycodone tablets can reduce the potential for abuse while effectively managing pain. Participants will undergo six sessions where they'll receive different combinations of these drugs (including placebos) to assess their impact on pain perception and brain activity.
Participant Groups
6Treatment groups
Active Control
Placebo Group
Group I: oxytocin+placeboActive Control2 Interventions
Separate effects of oxytocin. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Group II: Oral oxycodone (2.5mg) + intranasal placeboActive Control2 Interventions
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Group III: Oral oxycodone (5mg) + intranasal placeboActive Control2 Interventions
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
Group IV: oxycodone (5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin
Group V: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin
Group VI: placebo+placeboPlacebo Group2 Interventions
Serves as the control

oxycodone is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as OxyContin for:
  • Severe pain
  • Chronic pain
🇨🇦
Approved in Canada as OxyContin for:
  • Severe pain
  • Chronic pain
🇪🇺
Approved in European Union as OxyContin for:
  • Severe pain
  • Chronic pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

A study found that oxycodone hydrochloride injection is both safe and effective for use in negative pressure aspiration procedures.
Administering a dose of 0.08 mg/kg significantly reduces postoperative uterine contraction pain in patients suffering from dysmenorrhea.
The efficacy and safety of oxycodone in treating the uterine contraction pain after negative pressure aspiration: A randomized, compared, multicenter clinical study.Wang, YN., Xu, MJ., Feng, Y., et al.[2023]
A low-dose combination of oxycodone (average 8.68 mg) and acetaminophen (325 mg) effectively reduced moderate pain from an average score of 5.68 to 2.49 over approximately 21.6 days in a study of 491 patients.
Nearly 97% of patients experienced pain relief with just 5 mg doses of oxycodone combined with acetaminophen, suggesting this combination may minimize the risk of adverse reactions and dependence associated with higher opioid doses.
Retrospective Evaluation of a Fixed-Dose Combination of Oxycodone and Acetaminophen to Manage Moderate Pain: The Lower the Better.Natoli, S., Lazzari, M., Carpenedo, R., et al.[2018]
The combination of oxycodone and paracetamol provides a synergistic effect for treating moderate-to-severe chronic pain, allowing for lower doses of each drug to be used, which can reduce the risk of side effects.
This fixed-dose combination has been shown to be effective and well-tolerated across various clinical settings, including osteoarthritis, chronic musculoskeletal pain, and cancer-related pain, making it a strong candidate for first-line treatment in chronic pain management.
Oxycodone/paracetamol: a low-dose synergic combination useful in different types of pain.Gatti, A., Sabato, E., Di Paolo, AR., et al.[2021]

References

The efficacy and safety of oxycodone in treating the uterine contraction pain after negative pressure aspiration: A randomized, compared, multicenter clinical study. [2023]
Retrospective Evaluation of a Fixed-Dose Combination of Oxycodone and Acetaminophen to Manage Moderate Pain: The Lower the Better. [2018]
Oxycodone/paracetamol: a low-dose synergic combination useful in different types of pain. [2021]
Role of oxycodone and oxycodone/naloxone in cancer pain management. [2022]
Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. [2019]
Spontaneously reported adverse drug events related to tapentadol and oxycodone/naloxone in Australia. [2022]
Oxycodone/naloxone versus tapentadol in real-world chronic non-cancer pain management: an observational and pharmacogenetic study. [2022]
Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone. [2020]
Fixed ratio (2:1) prolonged-release oxycodone/naloxone combination improves bowel function in patients with moderate-to-severe pain and opioid-induced constipation refractory to at least two classes of laxatives. [2018]
Up-regulation of oxytocin receptors on peripheral sensory neurons mediates analgesia in chemotherapy-induced neuropathic pain. [2023]
Intrathecal oxytocin inhibits visceromotor reflex and spinal neuronal responses to noxious distention of the rat urinary bladder. [2022]
12.Korea (South)pubmed.ncbi.nlm.nih.gov
Brain uptake and the analgesic effect of oxytocin--its usefulness as an analgesic agent. [2019]
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]
14.United Statespubmed.ncbi.nlm.nih.gov
Evaluating the efficacy of oxytocin for pain management: An updated systematic review and meta-analysis of randomized clinical trials and observational studies. [2023]