Oxytocin + Oxycodone for Opioid Use Disorder

Phase < 1

Recruiting

Led By Meredith S 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Summary

This trial will test if combining oxytocin with oxycodone can reduce pain and abuse liability, while improving decision-making.

Who is the study for?

This trial is for English-speaking adults who have used opioids at least once, with normal blood pressure, heart rate, EKG, and bloodwork. They should be near their ideal body weight and not in chronic pain. Excluded are those with severe diseases or psychiatric disorders, pregnant or nursing women, individuals seeking drug abuse treatment, or those with substance use disorders other than nicotine or caffeine.

What is being tested?

The study tests if oxytocin nasal spray can reduce the addictive potential of oxycodone and enhance its pain relief effects. Participants will undergo six sessions where they'll receive combinations of oxycodone (5 mg or 2.5 mg), placebo tablets, oxytocin spray (48 IU), and placebo sprays to assess their impact on pain response and decision-making.

What are the potential side effects?

Possible side effects may include typical opioid-related issues like nausea, drowsiness, constipation from oxycodone; oxytocin might cause temporary discomfort at the site of nasal application or headaches.

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

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Oral oxycodone (5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions

Combined effects of oxycodone and oxytocin.

Group II: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions

Combined effects of oxycodone and oxytocin.

Group III: Oral placebo + intranasal oxytocin (48 IU)Active 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 IV: 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 V: Oral oxycodone (2.5mg) + intranasal placeboActive Control2 Interventions

Group VI: Oral placebo + intranasal placeboPlacebo Group2 Interventions

Serves as the control.

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