Understanding Cognition, Oxytocin & Pain in Elders

NCT03878589 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB201801467-NR01AG059809OCR18586
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC Pain (0-20 Scale)

  The WOMAC Pain subscale measures self-reported knee pain severity during daily activities. The subscale consists of 5 items assessing pain during walking, stair climbing, nocturnal pain, pain at rest, and weight-bearing activities. Each item is scored 0-4 (0=none, 4=extreme), yielding a total Pain subscale score of 0-20. Higher scores indicate greater pain severity. Change scores were calculated as post-treatment minus baseline; negative values indicate improvement (reduced pain).

  Baseline -> Week 4

Study Arms (2)

Oxytocin Crossover Placebo Group

ACTIVE COMPARATOR

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

Drug: Oxytocin (OT); Drug: Placebo (P)

Placebo Crossover Oxytocin Group

ACTIVE COMPARATOR

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

Drug: Oxytocin (OT); Drug: Placebo (P)

Interventions

Oxytocin (OT) DRUG

During the 4 week intervention, participants will self-administer twice daily 24 International Units 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.

Oxytocin Crossover Placebo Group; Placebo Crossover Oxytocin Group

Placebo (P) DRUG

During the 4 week intervention, participants will self-administer twice daily 24 International Units 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.

Oxytocin Crossover Placebo Group; Placebo Crossover Oxytocin Group

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Visual Descriptor Scale), and who have elevated levels of plasma Imterleukin-6 (\>2.5 pg/ml) will be considered for participation.

You may not qualify if:

• 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 osteoarthritis-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);

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Department of Community Dentistry and Behavioral Science

Gainesville, Florida, 32603, United States

Location

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Cruz-Almeida Y, Montesino-Goicolea S, Valdes-Hernandez P, Huo Z, Staud R, Ebner NC. Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain. Trials. 2025 Feb 7;26(1):44. doi: 10.1186/s13063-024-08715-4.

  PMID: 39920837 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Eric Weber
• Organization: University of Florida

ebweber@ufl.edu

3522737802

Study Officials

• Yenisel Cruz-Almeida, PhD, MSPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial will be a double-blinded, randomized crossover group design that will randomize older adults with symptomatic knee Osteoarthritis 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).

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: August 6, 2019
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)