PainEarly Phase 1NCT05761860
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
A Early Phase 1 study testing OxyCODONE 5 mg Oral Tablet, OxyCODONE 2.5 mg Oral Tablet and Oxytocin Nasal Spray (48 IU) in people with Pain, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- OxyCODONE 5 mg Oral Tablet, OxyCODONE 2.5 mg Oral Tablet and Oxytocin Nasal Spray (48 IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Lauren E Nieder, MSPH, 352-294-1067, lauren.nieder@ufl.edu
Meredith S Berry, PhD
About this study
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.
Read the detailed description
The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.
- Conditions
- Pain
- Being tested
- OxyCODONE 5 mg Oral Tablet, OxyCODONE 2.5 mg Oral Tablet, Placebo oxyCODONE Oral Tablet, Oxytocin Nasal Spray (48 IU), Placebo Oxytocin Nasal Spray
- Keywords
- Pain, Abuse liability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyCODONE 5 mg Oral TabletDrug
Oxycodone 5mg oral administration
OxyCODONE 2.5 mg Oral TabletDrug
Oxycodone 2.5mg oral administration
Placebo oxyCODONE Oral TabletOther
Oxycodone 0mg (placebo) oral administration
Oxytocin Nasal Spray (48 IU)Drug
Intranasal oxytocin administration (48 IU)
Placebo Oxytocin Nasal SprayOther
Intranasal oxytocin placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Oral oxycodone (5mg) + intranasal oxytocin (48 IU) | Active comparator | Combined effects of oxycodone and oxytocin. Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU) |
| Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU) | Active comparator | Combined effects of oxycodone and oxytocin. Receives: Drug: OxyCODONE 2.5 mg Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU) |
| Oral placebo + intranasal oxytocin (48 IU) | Active comparator | 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. Receives: Other: Placebo oxyCODONE Oral Tablet; Drug: Oxytocin Nasal Spray (48 IU) |
| Oral oxycodone (5mg) + intranasal placebo | Active comparator | 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. Receives: Drug: OxyCODONE 5 mg Oral Tablet; Other: Placebo Oxytocin Nasal Spray |
| Oral oxycodone (2.5mg) + intranasal placebo | Active comparator | 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. Receives: Drug: OxyCODONE 2.5 mg Oral Tablet; Other: Placebo Oxytocin Nasal Spray |
| Oral placebo + intranasal placebo | Sham comparator | Serves as the control. Receives: Other: Placebo oxyCODONE Oral Tablet; Other: Placebo Oxytocin Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-rated abuse liability
Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 6 sessions due to a minimum of a one week washout period in between each session.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start12 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a within-participant study so that each participant receives all conditions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Meredith S Berry, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761860
- Sponsor's protocol ID
- IRB202300435
- Other IDs
- 5R21DA056813-02
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
- ClinicalTrials.gov ID
- NCT05761860
- Acronym / sponsor ID
- IRB202300435
- Conditions
- Pain
- Keywords
- Pain, Abuse liability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a within-participant study so that each participant receives all conditions.
| Arm | Type | Receives |
|---|---|---|
| Oral oxycodone (5mg) + intranasal oxytocin (48 IU) | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Oxytocin Nasal Spray (48 IU)Combined effects of oxycodone and oxytocin. |
| Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU) | Active comparator | Drug: OxyCODONE 2.5 mg Oral Tablet, Drug: Oxytocin Nasal Spray (48 IU)Combined effects of oxycodone and oxytocin. |
| Oral placebo + intranasal oxytocin (48 IU) | Active comparator | Other: Placebo oxyCODONE Oral Tablet, Drug: Oxytocin Nasal Spray (48 IU)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. |
| Oral oxycodone (5mg) + intranasal placebo | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Other: Placebo Oxytocin Nasal SpraySeparate 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. |
| Oral oxycodone (2.5mg) + intranasal placebo | Active comparator | Drug: OxyCODONE 2.5 mg Oral Tablet, Other: Placebo Oxytocin Nasal SpraySeparate 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. |
| Oral placebo + intranasal placebo | Sham comparator | Other: Placebo oxyCODONE Oral Tablet, Other: Placebo Oxytocin Nasal SprayServes as the control. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxyCODONE 5 mg Oral TabletOxycodone 5mg oral administration | Drug | Oral oxycodone (5mg) + intranasal oxytocin (48 IU), Oral oxycodone (5mg) + intranasal placebo |
| OxyCODONE 2.5 mg Oral TabletOxycodone 2.5mg oral administration | Drug | Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU), Oral oxycodone (2.5mg) + intranasal placebo |
| Placebo oxyCODONE Oral TabletOxycodone 0mg (placebo) oral administration | Other | Oral placebo + intranasal oxytocin (48 IU), Oral placebo + intranasal placebo |
| Oxytocin Nasal Spray (48 IU)Intranasal oxytocin administration (48 IU) | Drug | Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU), Oral oxycodone (5mg) + intranasal oxytocin (48 IU), Oral placebo + intranasal oxytocin (48 IU) |
| Placebo Oxytocin Nasal SprayIntranasal oxytocin placebo administration | Other | Oral oxycodone (2.5mg) + intranasal placebo, Oral oxycodone (5mg) + intranasal placebo, Oral placebo + intranasal placebo |
Primary outcome
Subject-rated abuse liability
Time frame: Up to 6 weeks
Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 6 sessions due to a minimum of a one week washout period in between each session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meredith S Berry, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OxyCODONE 5 mg Oral Tablet, OxyCODONE 2.5 mg Oral Tablet and Oxytocin Nasal Spray (48 IU) in people with Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren E Nieder, MSPH ((352) 294-1067, lauren.nieder@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-rated abuse liability (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.