Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
NCT ID: NCT04218409
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
45 participants
INTERVENTIONAL
2021-09-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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oxycodone (5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
OxyCODONE 5 mg Oral Tablet
Oral oxycodone 5 mg orally
Oxytocin nasal spray
Intranasal oxytocin administration (48 IU)
Oral oxycodone (5mg) + intranasal placebo
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
OxyCODONE 5 mg Oral Tablet
Oral oxycodone 5 mg orally
Placebo oxytocin
Intranasal placebo administration
oxytocin+placebo
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
Oxytocin nasal spray
Intranasal oxytocin administration (48 IU)
Placebo Oxycodone
Oxycodone 0 mg orally
placebo+placebo
Serves as the control
Placebo Oxycodone
Oxycodone 0 mg orally
Placebo oxytocin
Intranasal placebo administration
Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)
Combined effects of oxycodone and oxytocin
Oxytocin nasal spray
Intranasal oxytocin administration (48 IU)
OxyCODONE 2.5 mg Oral Tablet
Oral oxycodone 2.5 mg orally
Oral oxycodone (2.5mg) + intranasal placebo
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
Placebo oxytocin
Intranasal placebo administration
OxyCODONE 2.5 mg Oral Tablet
Oral oxycodone 2.5 mg orally
Interventions
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OxyCODONE 5 mg Oral Tablet
Oral oxycodone 5 mg orally
Oxytocin nasal spray
Intranasal oxytocin administration (48 IU)
Placebo Oxycodone
Oxycodone 0 mg orally
Placebo oxytocin
Intranasal placebo administration
OxyCODONE 2.5 mg Oral Tablet
Oral oxycodone 2.5 mg orally
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 metal (unless able to demonstrate participant is MRI safe), and claustrophobia.
21 Years
45 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Meredith Berry, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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OCR30384
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201902618-N
Identifier Type: -
Identifier Source: org_study_id