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

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Primary Purpose

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

OxyCODONE 5 mg Oral Tablet

OxyCODONE 2.5 mg Oral Tablet

Placebo oxyCODONE Oral Tablet

Oxytocin Nasal Spray (48 IU)

Placebo Oxytocin Nasal Spray

About this trial

This is an interventional basic science trial for Pain focused on measuring Pain, Abuse liability

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Sham Comparator

Arm Label

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

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

Oral placebo + intranasal oxytocin (48 IU)

Oral oxycodone (5mg) + intranasal placebo

Oral oxycodone (2.5mg) + intranasal placebo

Oral placebo + intranasal placebo

Arm Description

Combined effects of oxycodone and oxytocin.

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.

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.

Serves as the control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05761860

First Posted

February 27, 2023

Last Updated

August 30, 2023

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT05761860

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Pain, Abuse liability

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

Combined effects of oxycodone and oxytocin.

Arm Title

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

Arm Type

Active Comparator

Arm Description

Combined effects of oxycodone and oxytocin.

Arm Title

Oral placebo + intranasal oxytocin (48 IU)

Arm Type

Active Comparator

Arm 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.

Arm Title

Oral oxycodone (5mg) + intranasal placebo

Arm Type

Active Comparator

Arm 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.

Arm Title

Oral oxycodone (2.5mg) + intranasal placebo

Arm Type

Active Comparator

Arm 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.

Arm Title

Oral placebo + intranasal placebo

Arm Type

Sham Comparator

Arm Description

Serves as the control.

Intervention Type

Drug

Intervention Name(s)

OxyCODONE 5 mg Oral Tablet

Intervention Description

Oxycodone 5mg oral administration

Intervention Type

Drug

Intervention Name(s)

OxyCODONE 2.5 mg Oral Tablet

Intervention Description

Oxycodone 2.5mg oral administration

Intervention Type

Other

Intervention Name(s)

Placebo oxyCODONE Oral Tablet

Intervention Description

Oxycodone 0mg (placebo) oral administration

Intervention Type

Drug

Intervention Name(s)

Oxytocin Nasal Spray (48 IU)

Intervention Description

Intranasal oxytocin administration (48 IU)

Intervention Type

Other

Intervention Name(s)

Placebo Oxytocin Nasal Spray

Intervention Description

Intranasal oxytocin placebo administration

Primary Outcome Measure Information:

Title

Subject-rated abuse liability

Description

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.

Time Frame

Up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren E Nieder, MSPH

Phone

(352) 294-1067

Email

lauren.nieder@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meredith S Berry, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren E Nieder, MSPH

Phone

352-294-1067

Email

lauren.nieder@ufl.edu

First Name & Middle Initial & Last Name & Degree

Meredith S Berry, PhD

12. IPD Sharing Statement

Plan to Share IPD

No

Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial