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New treatment option for Pain
Official title Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
ClinicalTrials.gov ID: NCT04218409
What this study is testing
What is OxyCODONE 5 mg Oral Tablet?
OxyCODONE 5 mg Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Individuals fluent in English will participate.
- Must report recreational use of opioids.
- Be within 20% of their ideal body weight.
- Are not currently experiencing chronic pain (pain on most days during the past 3 months)
- Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute.
You likely can't join if
- Significant current physical disease or major psychiatric disorder.
- No self-reported current interest in drug abuse treatment.
- Women who are pregnant or nursing.
- Any comorbid illicit substance use disorders or current clinically significant withdrawal for 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...
See the full eligibility criteria
- Individuals fluent in English will participate.
- Must report recreational use of opioids.
- Be within 20% of their ideal body weight.
- Are not currently experiencing chronic pain (pain on most days during the past 3 months)
- Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute.
- Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.
- Significant current physical disease or major psychiatric disorder.
- No self-reported current interest in drug abuse treatment.
- Women who are pregnant or nursing.
- Any comorbid illicit substance use disorders or current clinically significant withdrawal for 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.