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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761860
• Other study ID #: IRB202300435
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 12, 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: Lauren E Nieder, MSPH
• Phone: (352) 294-1067
• Email: lauren.nieder[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 effects, and decision-making.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Pain

Intervention

Drug:
• OxyCODONE 5 mg Oral Tablet
Oxycodone 5mg oral administration
• OxyCODONE 2.5 mg Oral Tablet
Oxycodone 2.5mg oral administration

Other:
• Placebo oxyCODONE Oral Tablet
Oxycodone 0mg (placebo) oral administration

Drug:
• Oxytocin Nasal Spray (48 IU)
Intranasal oxytocin administration (48 IU)

Other:
• Placebo Oxytocin Nasal Spray
Intranasal oxytocin placebo administration

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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