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Opioid Analgesic

Oxytocin + Oxycodone for Pain

Phase < 1

Recruiting

Led By Meredith Berry, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are not currently experiencing chronic pain (pain on most days during the past 3 months)

Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.

Must not have

Women who are pregnant or nursing.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks.

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial will study whether taking oxytocin with oxycodone may reduce abuse liability and improve pain reduction.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include typical opioid-related issues like nausea, drowsiness, constipation or addiction risk. Oxytocin could cause nasal irritation or headaches. The combination's effects on decision-making and neural activation are also under scrutiny.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had chronic pain in the last 3 months.

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My heart's electrical activity is normal and my blood tests show no major health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subject-rated abuse liability

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

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

0 / 3Eligibility criteria met