Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Sustained Positive Emotions; Sustained Positive Behavior Change

Treatments: Drug: Placebo (for oxytocin); Behavioral: Lovingkindness Meditation; Behavioral: Mindfulness Meditation; Drug: Oxytocin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01929161

R01NR012899-03S2 (U.S. NIH Grant/Contract)

12-2371 IRB

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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239 participants in 4 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Meditation

Drug: Oxytocin

Behavioral: Lovingkindness Meditation

Placebo (for oxytocin)

Placebo Comparator group

Description:

Intranasal spray with all equivalent ingredients except oxytocin

Treatment:

Behavioral: Mindfulness Meditation

Drug: Placebo (for oxytocin)

Behavioral: Lovingkindness Meditation

Lovingkindness Meditation

Experimental group

Description:

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

Treatment:

Drug: Oxytocin

Drug: Placebo (for oxytocin)

Behavioral: Lovingkindness Meditation

Mindfulness Meditation

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness Meditation

Drug: Oxytocin

Drug: Placebo (for oxytocin)