Recruiting EARLY_PHASE1 Pain

New treatment option for Pain

Official title The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

ClinicalTrials.gov ID: NCT05761860

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, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.
  • 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 45 to 85. Healthy volunteers may be eligible.

You may be able to join if

  • Individuals fluent in English will participate.
  • Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime).
  • 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 (uncontrolled) psychiatric disorder.
  • No self-reported current interest in drug abuse treatment.
  • Women who are pregnant or nursing.
  • Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
See the full eligibility criteria
Who can join
  • Individuals fluent in English will participate.
  • Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime).
  • 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.
What rules you out
  • Significant current physical disease or major (uncontrolled) psychiatric disorder.
  • No self-reported current interest in drug abuse treatment.
  • Women who are pregnant or nursing.
  • Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.

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, 45 years to 85 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.