Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

NCT ID: NCT01929161

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and thereby increases nonconscious motives that shape daily behavioral decisions to repeat it, which in turn foster positive emotions that further augment nonconscious motives in an upward spiral dynamic.

The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e., moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion yield of meditation, which varies by experimental condition, increases the nonconscious incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict positive emotions, sparking the relationships among OT manipulation, positive emotion yield, and nonconscious incentive salience of Wellness Behavior-related cues.

Detailed Description

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Conditions

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Sustained Positive Emotions Sustained Positive Behavior Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin

Oxytocin intranasal spray, 6 intranasal sufflations which deliver a total of 24 international units of oxytocin

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

24 International Units

Lovingkindness Meditation

Intervention Type BEHAVIORAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

Placebo (for oxytocin)

Intranasal spray with all equivalent ingredients except oxytocin

Group Type PLACEBO_COMPARATOR

Placebo (for oxytocin)

Intervention Type DRUG

intranasal spray manufactured to mimic oxytocin nasal spray

Lovingkindness Meditation

Intervention Type BEHAVIORAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

Lovingkindness Meditation

Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

24 International Units

Placebo (for oxytocin)

Intervention Type DRUG

intranasal spray manufactured to mimic oxytocin nasal spray

Lovingkindness Meditation

Intervention Type BEHAVIORAL

Mindfulness Meditation

Mindfulness guided meditation experienced in the laboratory and 6 additional Mindfulness meditations taken home on the iPod.

Group Type PLACEBO_COMPARATOR

Oxytocin

Intervention Type DRUG

24 International Units

Placebo (for oxytocin)

Intervention Type DRUG

intranasal spray manufactured to mimic oxytocin nasal spray

Mindfulness Meditation

Intervention Type BEHAVIORAL

Interventions

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Oxytocin

24 International Units

Intervention Type DRUG

Placebo (for oxytocin)

intranasal spray manufactured to mimic oxytocin nasal spray

Intervention Type DRUG

Lovingkindness Meditation

Intervention Type BEHAVIORAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

Other Intervention Names

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Syntocinon

Eligibility Criteria

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Inclusion Criteria

* between the ages of 35 and 64 years old.
* Fluent in written and spoken English
* Willingness or interest in learning to meditate
* Computer literate with access to internet (weekly)

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Individuals on antihypertensive medication
* Individuals who have or have had a regular meditation practice
* Individuals who can read Chinese logographs
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Barbara L. Fredrickson, PhD

Kenan Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara L Fredrickson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC PEP Lab

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R01NR012899-03S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-2371 IRB

Identifier Type: -

Identifier Source: org_study_id

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