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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a within-participant study so that each participant receives all conditions.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Oral oxycodone (5mg) + intranasal oxytocin (48 IU)

Combined effects of oxycodone and oxytocin.

Group Type ACTIVE_COMPARATOR

OxyCODONE 5 mg Oral Tablet

Intervention Type DRUG

Oxycodone 5mg oral administration

Oxytocin Nasal Spray (48 IU)

Intervention Type DRUG

Intranasal oxytocin administration (48 IU)

Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)

Combined effects of oxycodone and oxytocin.

Group Type ACTIVE_COMPARATOR

OxyCODONE 2.5 mg Oral Tablet

Intervention Type DRUG

Oxycodone 2.5mg oral administration

Oxytocin Nasal Spray (48 IU)

Intervention Type DRUG

Intranasal oxytocin administration (48 IU)

Oral placebo + intranasal oxytocin (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.

Group Type ACTIVE_COMPARATOR

Placebo oxyCODONE Oral Tablet

Intervention Type OTHER

Oxycodone 0mg (placebo) oral administration

Oxytocin Nasal Spray (48 IU)

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

OxyCODONE 5 mg Oral Tablet

Intervention Type DRUG

Oxycodone 5mg oral administration

Placebo Oxytocin Nasal Spray

Intervention Type OTHER

Intranasal oxytocin placebo administration

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.

Group Type ACTIVE_COMPARATOR

OxyCODONE 2.5 mg Oral Tablet

Intervention Type DRUG

Oxycodone 2.5mg oral administration

Placebo Oxytocin Nasal Spray

Intervention Type OTHER

Intranasal oxytocin placebo administration

Oral placebo + intranasal placebo

Serves as the control.

Group Type SHAM_COMPARATOR

Placebo oxyCODONE Oral Tablet

Intervention Type OTHER

Oxycodone 0mg (placebo) oral administration

Placebo Oxytocin Nasal Spray

Intervention Type OTHER

Intranasal oxytocin placebo administration

Interventions

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OxyCODONE 5 mg Oral Tablet

Oxycodone 5mg oral administration

Intervention Type DRUG

OxyCODONE 2.5 mg Oral Tablet

Oxycodone 2.5mg oral administration

Intervention Type DRUG

Placebo oxyCODONE Oral Tablet

Oxycodone 0mg (placebo) oral administration

Intervention Type OTHER

Oxytocin Nasal Spray (48 IU)

Intranasal oxytocin administration (48 IU)

Intervention Type DRUG

Placebo Oxytocin Nasal Spray

Intranasal oxytocin placebo administration

Intervention Type OTHER

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes