Oxytocin and Social Behavior Over the Lifespan

NCT ID: NCT00914953

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

Brief Summary

This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.

Detailed Description

Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends. Because OT is associated with peri-reproductive behaviors, OT release in OAs is expected to be attenuated relative to younger adults. If OT release is low in OAs as we hypothesize, augmenting OT may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. Research in rodents suggests that social interactions themselves may change chronic OT levels (Carter & Keverne, 2002; Carter & Altemus, 1997), in a positive feedback loop. In order to demonstrate OT as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.

Conditions

Social Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

oxytocin

Group Type: EXPERIMENTAL

oxytocin (Pitocin)

Intervention Type: DRUG

40 IU OT intranasally (IN) once-daily for 10 consecutive days

Interventions

oxytocin (Pitocin)

40 IU OT intranasally (IN) once-daily for 10 consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• residentially housed
• English fluency

Exclusion Criteria

• non ambulatory
• severe psychiatric problems presently or in the recent past
• severe medical problems (e.g., cancer, diabetes, advanced heart disease)
• irregular heart beat
• treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or Ambien)
• inability to adequately communicate with the research team
• treatment with an experimental drug
• excessive fatigue suggesting hypothyroidism

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Claremont Graduate University

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Zak

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Linda Valley Villa

Loma Linda, California, United States

Countries

United States

Other Identifiers

NIH Grant 1R21AG029871-01A2

Identifier Type: -

Identifier Source: secondary_id

CNS-R21AG029871

Identifier Type: -

Identifier Source: org_study_id