Interpersonal Brain Function in Opioid Use

The purpose of this study is to assess dyadic physiological coherence and subjective empathic attunement during meditation practices and their association with opioid-related outcomes.

Study Overview

• Status: Recruiting
• Conditions: People Who Use Opioids/People With Opioid Use Disorder (OUD)
• Intervention / Treatment: Behavioral: Meditation; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Hendrickson, MS; Email: kehendrickson@health.ucsd.edu
• Study Contact Backup: Name: Lori Kroh, BS; Phone Number: 619-259-0735; Email: l1kroh@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Eric Garland, PhD; Phone Number: 858-822-4092; Email: egarland@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Persons, aged 18 or older
2. Current near daily use of prescribed or illicit opioid agonists or mixed opioid agonist-antagonists for ≥90 days
3. Must be able to speak and understand English

Exclusion Criteria:

1. Cognitive Impairment that would preclude participation in the research protocol
2. Active suicidal intent or psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation; 20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.	Behavioral: Meditation; 20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
Active Comparator: Psychoeducation; Psychoeducation about opioid neuropharmacology.	Behavioral: Psychoeducation; 20 minute psychoeducational script on the impact of opioid use on the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological synchrony	Dyadic Neural Synchrony (DNS) across electrodes and dyads will be computed from EEG oscillations using established inter-brain connectivity metrics. DNS will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's EEG activity. Higher DNS values indicate greater therapist-patient neural attunement.	During the intervention and for 5 minutes afterwards

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpersonal Attunement	Interpersonal attunement measured by the Interpersonal Attunement Rating Scale, a 0-10 numeric rating scale to assess sense of connection with the other person (0=no attunement, 10=very high attunement).	During Intervention
Opioid Craving	Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).	Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Opioid Use	Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.	Pre-Intervention, and 1 month Follow-Up
Severity of Pain	Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)	Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Affect	Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).	Pre-Intervention, during Intervention, and immediately post-Intervention.
State Self-Transcendence	Nondual awareness measured by the Nondual Awareness Dimensional Assessment Measure- State (NADA-S), with scores ranging from 0 to 30, with higher scores indicating greater self-transcendence	Pre-Intervention, during Intervention, immediately post-Intervention.
Metacognitive processes	Metacognitive Processes of Decentering Scale (MPODS), a 3-Item scale with scores ranging from 0 to 30, with higher scores indicating greater capacity for meta-awareness, non-reactivity, and disidentification.	Pre-Intervention, during Intervention, and immediately post-Intervention.
Cardiac-autonomic synchrony	Cardiac-autonomic synchrony (CAS) will be computed from heart rate variability. CAS will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's R-R intervals. Higher CAS values indicate greater therapist-patient autonomic attunement.	During the intervention and for 5 minutes afterwards
Facial expression synchrony	Facial Expression Synchrony (FES) will be assessed using automated facial expression analysis derived from computer-vision-based facial landmark and action-unit detection. FES will be quantified as a dyadic coupling parameter computed from time-series features extracted from each participant's facial expressions. Higher FES values indicate greater therapist-patient affective attunement	During the intervention and for 5 minutes afterwards

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Eric Garland, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy; Meditation
• Other Study ID Numbers: 813632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
• IPD Sharing Time Frame: Data will become available after the publication of the main study findings from the final data set. Data will be made permanently available.
• IPD Sharing Access Criteria: Data will be made available upon reasonable request with a signed data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No