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

University of Florida

Status and phase

Enrolling

Early Phase 1

Conditions

Pain

Treatments

Drug: OxyCODONE 2.5 mg Oral Tablet

Drug: Oxytocin Nasal Spray (48 IU)

Other: Placebo oxyCODONE Oral Tablet

Other: Placebo Oxytocin Nasal Spray

Drug: OxyCODONE 5 mg Oral Tablet

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05761860

IRB202300435

5R21DA056813-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

45 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

45 participants in 6 patient groups

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

Active Comparator group

Description:

Combined effects of oxycodone and oxytocin.

Treatment:

Drug: OxyCODONE 5 mg Oral Tablet

Drug: Oxytocin Nasal Spray (48 IU)

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

Active Comparator group

Description:

Combined effects of oxycodone and oxytocin.

Treatment:

Drug: Oxytocin Nasal Spray (48 IU)

Drug: OxyCODONE 2.5 mg Oral Tablet

Oral placebo + intranasal oxytocin (48 IU)

Active Comparator group

Description:

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.

Treatment:

Other: Placebo oxyCODONE Oral Tablet

Drug: Oxytocin Nasal Spray (48 IU)

Oral oxycodone (5mg) + intranasal placebo

Active Comparator group

Description:

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.

Treatment:

Other: Placebo Oxytocin Nasal Spray

Drug: OxyCODONE 5 mg Oral Tablet

Oral oxycodone (2.5mg) + intranasal placebo

Active Comparator group

Description:

Treatment:

Other: Placebo Oxytocin Nasal Spray

Drug: OxyCODONE 2.5 mg Oral Tablet

Oral placebo + intranasal placebo

Sham Comparator group

Description: