Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination

Pain Clinical Trial

Official title:

Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218409
• Other study ID #: IRB201902618-N
• Secondary ID: OCR303841K01DA05
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 2, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: University of Florida
• Contact: Lauren Nieder
• 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, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.

Description:

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. 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 MRI eligibility and 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: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Individuals fluent in English will participate.

• Must report recreational use of opioids.

• 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 psychiatric disorder.

• No self-reported current interest in drug abuse treatment.

• Women who are pregnant or nursing.

• Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.

• Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• OxyCODONE 5 mg Oral Tablet
Oral oxycodone 5 mg orally
• Oxytocin nasal spray
Intranasal oxytocin administration (48 IU)

Other:
• Placebo Oxycodone
Oxycodone 0 mg orally
• Placebo oxytocin
Intranasal placebo administration

Drug:
• OxyCODONE 2.5 mg Oral Tablet
Oral oxycodone 2.5 mg orally

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Drug Abuse (NIDA)

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 4 sessions due to a minimum of a one week washout period in between each session.	up to 6 weeks.