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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subject-rated abuse liability

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin
Group II: oxycodone (5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin
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: 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 V: 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 VI: placebo+placeboPlacebo Group2 Interventions
Serves as the control

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,919 Total Patients Enrolled
24 Trials studying Pain
3,159 Patients Enrolled for Pain
University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,311 Total Patients Enrolled
19 Trials studying Pain
1,912 Patients Enrolled for Pain
Meredith Berry, PhDPrincipal InvestigatorUniversity of Florida

Media Library

oxycodone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04218409 — Phase < 1
Pain Research Study Groups: placebo+placebo, Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU), oxycodone (5mg) + intranasal oxytocin (48 IU), Oral oxycodone (5mg) + intranasal placebo, oxytocin+placebo, Oral oxycodone (2.5mg) + intranasal placebo
Pain Clinical Trial 2023: oxycodone Highlights & Side Effects. Trial Name: NCT04218409 — Phase < 1
oxycodone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218409 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participating in this experiment?

"This study has an age range criterion of 21 to 45 years old. Patients younger or older than this range will be ineligible for enrollment."

Answered by AI

Is this trial looking to accept more participants at the present moment?

"At the moment, this medical investigation is searching for participants to join. Initially posted on December 1st 2022 and edited lastly on November 17th 2022, clinicaltrials.gov has documented these details."

Answered by AI

Am I a suitable candidate to take part in this research endeavor?

"This medical experiment is enrolling 45 individuals aged 21 - 45 who currently experience acute pain. To qualify, participants must be proficient in English and report any recreational opioid use. Furthermore, they must also maintain a body mass index within 20% of their ideal weight, not have chronic pain (discomfort on most days during the past 3 months), possess systolic blood pressure less than or equal to 140 mmHg with diastolic blood pressure <= 90mmHg and heart rate lower than or equal to 90 beats per minute; additionally having a normal electrocardiogram readout as well as healthy clinical lab results are paramount for eligibility"

Answered by AI

How many individuals may take part in this research endeavor?

"Affirmative. The information on clinicaltrials.gov attests that this research is currently recruiting participants - the initial post was made on December 1st 2022, and it has been recently revised as of November 17th 2022. 45 individuals must be recruited from a single site."

Answered by AI

How is the combination of oxycodone and oxytocin typically employed therapeutically?

"Oxycodone+oxytocin is employed to treat inevitable abortion and additional conditions, like incomplete labor, uterine contraction, and miscarriage."

Answered by AI

What precedent exists for the combination of oxycodone and oxytocin in scientific research?

"Currently, 77 oxycodone+oxytocin clinical trials are taking place with 15 in Phase 3. Omaha, Nebraska is the primary hub of these studies; however 124 medical sites host these trials across the country."

Answered by AI
~24 spots leftby Dec 2026