Trial Outcomes & Findings for Understanding Cognition, Oxytocin & Pain in Elders (NCT NCT03878589)

Last Updated: 2026-02-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

83 participants

Primary outcome timeframe

Baseline -> Week 4

Results posted on

2026-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin Crossover Placebo Group 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. Oxytocin (OT): 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. Placebo (P): 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.	Placebo Crossover Oxytocin Group 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. Oxytocin (OT): 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. Placebo (P): 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.
Overall Study STARTED	41	42
Overall Study COMPLETED	21	24
Overall Study NOT COMPLETED	20	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Understanding Cognition, Oxytocin & Pain in Elders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin Crossover Placebo Group n=41 Participants 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. Oxytocin (OT): 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. Placebo (P): 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.	Placebo Crossover Oxytocin Group n=42 Participants 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. Oxytocin (OT): 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. Placebo (P): 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.	Total n=83 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 7.4 • n=58 Participants	67.1 years STANDARD_DEVIATION 9.0	68.0 years STANDARD_DEVIATION 8.3 • n=1 Participants
Sex: Female, Male Female	29 Participants n=58 Participants	27 Participants	56 Participants n=1 Participants
Sex: Female, Male Male	12 Participants n=58 Participants	15 Participants	27 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants	0 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Asian	0 Participants n=58 Participants	0 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants	0 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	2 Participants n=58 Participants	9 Participants	11 Participants n=1 Participants
Race (NIH/OMB) White	38 Participants n=58 Participants	33 Participants	71 Participants n=1 Participants
Race (NIH/OMB) More than one race	0 Participants n=58 Participants	0 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=58 Participants	0 Participants	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline -> Week 4

Outcome measures

Outcome measures
Measure	Oxytocin n=55 Participants Intranasal oxytocin 24 IU twice daily for 4 weeks	Placebo n=51 Participants Matching placebo twice daily for 4 weeks
Change in WOMAC Pain (0-20 Scale)	-0.14 units on a scale Standard Deviation 2.92	-0.65 units on a scale Standard Deviation 3.03

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxytocin n=66 participants at risk Intranasal oxytocin 24 IU twice daily for 4 weeks	Placebo n=68 participants at risk Matching placebo twice daily for 4 weeks
Nervous system disorders Autonomic dysfunction (vertigo, SOB, chest pain)	0.00% 0/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	1.5% 1/68 • Number of events 1 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	1.5% 1/68 • Number of events 1 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Nervous system disorders Diplopia and dizziness	0.00% 0/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	1.5% 1/68 • Number of events 1 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).

Other adverse events

Other adverse events
Measure	Oxytocin n=66 participants at risk Intranasal oxytocin 24 IU twice daily for 4 weeks	Placebo n=68 participants at risk Matching placebo twice daily for 4 weeks
Nervous system disorders Drowsiness/sleepiness	24.2% 16/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	35.3% 24/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Nervous system disorders Headaches	24.2% 16/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	27.9% 19/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Nervous system disorders Light headedness/vertigo	3.0% 2/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	8.8% 6/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
General disorders Fatigue	25.8% 17/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	33.8% 23/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Respiratory, thoracic and mediastinal disorders Nasal symptoms (congestion, runny nose, irritation)	39.4% 26/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	44.1% 30/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Respiratory, thoracic and mediastinal disorders Throat symptoms (dry/sore throat, hoarseness)	19.7% 13/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	20.6% 14/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Respiratory, thoracic and mediastinal disorders Cough/sneezing	30.3% 20/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	32.4% 22/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Psychiatric disorders Mood/anxiety changes	21.2% 14/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	30.9% 21/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Gastrointestinal disorders GI symptoms (constipation, diarrhea, nausea)	21.2% 14/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	19.1% 13/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Cardiac disorders Cardiovascular (chest pain, BP changes, palpitations)	9.1% 6/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	14.7% 10/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Renal and urinary disorders Urinary changes	7.6% 5/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	4.4% 3/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).
Skin and subcutaneous tissue disorders Skin symptoms (rash, itching, tingling)	12.1% 8/66 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).	16.2% 11/68 • During each 4-week treatment period (8 weeks total across both crossover periods) Adverse events were collected systematically via weekly telephone symptom checklists during each 4-week treatment period. Participants reported the presence and severity of 45 predefined symptoms. Serious adverse events were defined per FDA criteria (death, life-threatening, hospitalization, persistent disability, or medically important event).

Additional Information

Eric Weber

University of Florida

Phone: 3522737802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place