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Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

Affective and Genomic Mediators of Sustained Behavior Change: A Randomized, Dual-blind, Placebo-controlled Experimental Design That Will Examine Wellness Behavior as a Function of Oxytocin vs. Placebo.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01929161
Enrollment
239
Registered
2013-08-27
Start date
2013-09-30
Completion date
2014-09-30
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sustained Positive Behavior Change, Sustained Positive Emotions

Keywords

positive emotions, meditation, oxytocin

Brief summary

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.

Interventions

DRUGOxytocin

24 International Units

DRUGPlacebo (for oxytocin)

intranasal spray manufactured to mimic oxytocin nasal spray

BEHAVIORALLovingkindness Meditation
BEHAVIORALMindfulness Meditation

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in positive emotions (as measured by the Modified Daily Emotions Scale)Baseline and Weeks 1, 2, and 3Modified Daily Emotions Scale (mDES) - This measure of explicit positive affect has been successfully used by the PI in multiple studies to detect changes in positive emotion. Previous work by the PI found that Cronbach's alpha coefficient for the mDES positive emotion composite variable was 0.93 in sample of mid-life community adults similar to those anticipated for this study.
Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).Baseline and Weeks 1, 2, and 3Affect Misattribution Procedure (AMP) - This measure of nonconscious incentive salience has acceptable internal consistency for an indirect measure of affect (.69 - .90) and has been found to predict judgments and behavioral outcomes above and beyond self-report measures.
Changes in meditation timeWeeks 1, 2, and 3Self-reported meditation time recorded daily and weekly. In addition, meditation track play times will be recorded from the iPod.

Secondary

MeasureTime frameDescription
Cardiac Vagal ToneBaselineThis measure of parasympathetic control over the heart has been positively associated with both emotional and social functioning. Previous work by the PI's team has found that baseline vagal tone predicts increased positive response to lovingkindness meditation (LKM), and that LKM in turn increases vagal tone. Previous research by other labs has also found that OT administration increases vagal reactivity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026