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Completed

NCT Number: NCT00914953

Oxytocin and Social Behavior Over the Lifespan

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Linda Valley Villa

Loma Linda, California, 92354-3135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxytocin (Pitocin)

Drug

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

Primary outcomes

  1. confirm increased social activities in treatment condition compared to control condition via self-report.

    Time frame: 30 days

Secondary outcomes

  1. Evidence of greater psychological health for treatment condition as compared to control condition.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Claremont Graduate University

Other

Registry information

Official study title

Oxytocin and Social Behavior Over the Lifespan: Interventional Study

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jun 5, 2009
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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