The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

Conditions
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Pain

Intervention / Treatment
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* Drug: OxyCODONE 5 mg Oral Tablet
* Drug: OxyCODONE 2.5 mg Oral Tablet
* Other: Placebo oxyCODONE Oral Tablet
* Drug: Oxytocin Nasal Spray (48 IU)
* Other: Placebo Oxytocin Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a within-participant study so that each participant receives all conditions.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral oxycodone (5mg) + intranasal oxytocin (48 IU)<br>Combined effects of oxycodone and oxytocin. | Drug: OxyCODONE 5 mg Oral Tablet<br>* Oxycodone 5mg oral administration<br>Drug: Oxytocin Nasal Spray (48 IU)<br>* Intranasal oxytocin administration (48 IU)<br>|
| Active Comparator: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)<br>Combined effects of oxycodone and oxytocin. | Drug: OxyCODONE 2.5 mg Oral Tablet<br>* Oxycodone 2.5mg oral administration<br>Drug: Oxytocin Nasal Spray (48 IU)<br>* Intranasal oxytocin administration (48 IU)<br>|
| Active Comparator: Oral placebo + intranasal oxytocin (48 IU)<br>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. | Other: Placebo oxyCODONE Oral Tablet<br>* Oxycodone 0mg (placebo) oral administration<br>Drug: Oxytocin Nasal Spray (48 IU)<br>* Intranasal oxytocin administration (48 IU)<br>|
| Active Comparator: Oral oxycodone (5mg) + intranasal placebo<br>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. | Drug: OxyCODONE 5 mg Oral Tablet<br>* Oxycodone 5mg oral administration<br>Other: Placebo Oxytocin Nasal Spray<br>* Intranasal oxytocin placebo administration<br>|
| Active Comparator: Oral oxycodone (2.5mg) + intranasal placebo<br>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. | Drug: OxyCODONE 2.5 mg Oral Tablet<br>* Oxycodone 2.5mg oral administration<br>Other: Placebo Oxytocin Nasal Spray<br>* Intranasal oxytocin placebo administration<br>|
| Sham Comparator: Oral placebo + intranasal placebo<br>Serves as the control. | Other: Placebo oxyCODONE Oral Tablet<br>* Oxycodone 0mg (placebo) oral administration<br>Other: Placebo Oxytocin Nasal Spray<br>* Intranasal oxytocin placebo administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Abuse liability