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Understanding Cognition, Oxytocin & Pain in Elders (UCOPE)

Primary Purpose

Knee Osteoarthritis, Osteoarthritis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Oxytocin (OT)

Placebo (P)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

knee osteoarthritis/or back pain of at least six months duration, experience pain on more days than not, with moderate pain at baseline (i.e., > 3/6 in the VDS), and who have elevated levels of plasma IL-6 (>2.5 pg/ml) will be considered for participation.

Exclusion Criteria:

Hypersensitivity to OT or vasopressin,
history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia,
on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication,
low sodium and high osmolality levels,
excessive smoking,
excessive drinking,
muscle pain as a result of systemic disease,
significant nasal pathology,
previous or concurrent use of narcotics delivered intranasally (e.g., cocaine),
gastroparesis.
individuals with heart problems (e.g., cardiomyopathy, history of myocardial infarction, arrhythmias, prolonged QT interval)
Participants will also be excluded if they have concurrent medical or arthritic conditions that could confound symptomatic knee OA-related outcomes or coexisting disease that could preclude successful completion of the protocol including:
systemic rheumatic condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia);
a history of clinically significant surgery to the index knee;
uncontrolled hypertension (>150/95);
poorly controlled diabetes (HbA1c>7%);
neurological disease (e.g., Parkinson's, Multiple Sclerosis);
cardiovascular or peripheral arterial disease;
serious psychiatric disorder requiring hospitalization within the past twelve months or characterized by active suicidal ideation;
diminished cognitive function that would interfere with completion of study procedures (i.e., MoCA score < 25)]; and
large pieces of metal in the body or metal in the face or neck,
claustrophobia,
major medical surgery in the past two months,
history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures].
pregnant individuals will be excluded

Sites / Locations

Department of Community Dentistry and Behavioral ScienceRecruiting
UF Health of University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oxytocin Crossover Placebo Group

Placebo Crossover Oxytocin Group

Arm Description

During Phase 1 of the intervention, participants will self-administer via intranasal spray 24 IUs of oxytocin (OT) twice a day at home, at 8-9AM and again at 5-6PM. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 IUs of placebo (P) twice a day will be self-administered.

During Phase 1 of the intervention, participants will self-administer via intranasal spray 24 IUs of placebo (P) twice a day at home, at 8-9AM and again at 5-6PM. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 IUs of oxytocin (OT) twice a day will be self-administered.

Outcomes

Primary Outcome Measures

Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index

Self-reported pain and function. Summary scores of the WOMAC range from 0 (No pain or disability) to 96 (Extreme pain or disability).

Secondary Outcome Measures

Change in Frontal Cortex Brain Metabolites

Track levels of the frontal cortex brain chemicals (tCr, MI, Cho) through use of magnetic resonance spectroscopy (MRS).

Full Information

NCT ID

NCT03878589

First Posted

March 12, 2019

Last Updated

June 8, 2023

Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03878589

Brief Title

Understanding Cognition, Oxytocin & Pain in Elders

Acronym

UCOPE

Official Title

Mechanisms Underlying Oxytocin's Analgesia in Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 6, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals relative to placebo (P) evaluating its effects on pain and function in aging and testing potential underlying neurobiological mechanisms.

Detailed Description

Osteoarthritis (OA) represents a significant cause of disability worldwide in individuals aged 65 and older, a rapidly growing segment of our population. The knee is the most commonly affected joint with pain being the primary symptom, negatively impacting physical, cognitive, and emotional functioning. Symptomatic knee OA has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of OA-related pain. The neuropeptide oxytocin (OT) has been recognized as a mediator of endogenous analgesia in animal and human studies. However, little is known about the neurobiological mechanisms underlying OT's pain-relieving properties. This study will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals with knee osteoarthritis. Relative to placebo (P), daily administration of intranasal OT diminished self-reported pain, physical and emotional functioning and changes in brain metabolite concentrations. With strong support from the University of Florida and the McKnight Brain Institute, this interdisciplinary project, using a comprehensive multi-methods approach, will be the first to determine the potential benefit of OT as a novel analgesic therapy for knee OA pain in aging.

6. Conditions and Keywords

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

Knee Osteoarthritis, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Model Description

This trial will be a double-blinded, randomized crossover group design that will randomize older adults with symptomatic knee OA pain to four weeks of intranasal self-administration of either oxytocin (OT) or placebo (P) (48 IUs daily) followed by a four-week washout period and a second four weeks of intervention (either OT or P).

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin Crossover Placebo Group

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo Crossover Oxytocin Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oxytocin (OT)

Intervention Description

During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal oxytocin (OT) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.

Intervention Type

Drug

Intervention Name(s)

Placebo (P)

Intervention Description

During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal placebo (P) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.

Primary Outcome Measure Information:

Title

Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index

Description

Self-reported pain and function. Summary scores of the WOMAC range from 0 (No pain or disability) to 96 (Extreme pain or disability).

Time Frame

Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12

Secondary Outcome Measure Information:

Title

Change in Frontal Cortex Brain Metabolites

Description

Track levels of the frontal cortex brain chemicals (tCr, MI, Cho) through use of magnetic resonance spectroscopy (MRS).

Time Frame

Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: knee osteoarthritis/or back pain of at least six months duration, experience pain on more days than not, with moderate pain at baseline (i.e., > 3/6 in the VDS), and who have elevated levels of plasma IL-6 (>2.5 pg/ml) will be considered for participation. Exclusion Criteria: Hypersensitivity to OT or vasopressin, history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia, on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication, low sodium and high osmolality levels, excessive smoking, excessive drinking, muscle pain as a result of systemic disease, significant nasal pathology, previous or concurrent use of narcotics delivered intranasally (e.g., cocaine), gastroparesis. individuals with heart problems (e.g., cardiomyopathy, history of myocardial infarction, arrhythmias, prolonged QT interval) Participants will also be excluded if they have concurrent medical or arthritic conditions that could confound symptomatic knee OA-related outcomes or coexisting disease that could preclude successful completion of the protocol including: systemic rheumatic condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia); a history of clinically significant surgery to the index knee; uncontrolled hypertension (>150/95); poorly controlled diabetes (HbA1c>7%); neurological disease (e.g., Parkinson's, Multiple Sclerosis); cardiovascular or peripheral arterial disease; serious psychiatric disorder requiring hospitalization within the past twelve months or characterized by active suicidal ideation; diminished cognitive function that would interfere with completion of study procedures (i.e., MoCA score < 25)]; and large pieces of metal in the body or metal in the face or neck, claustrophobia, major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures]. pregnant individuals will be excluded

Central Contact Person:

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

Yenisel Cruz-Almeida, PhD, MSPH

Phone

352-294-5845

cryeni@ufl.edu

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

Natalie Ebner, PhD

natalie.ebner@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yenisel Cruz-Almeida, PhD, MSPH

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Community Dentistry and Behavioral Science

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32603

Country

United States

Individual Site Status

Recruiting

Facility Name

UF Health of University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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