Interpersonal Brain Function in Opioid Use

NCT07386769 | Recruiting DMC

• 1 other identifier: 813632
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

People Who Use Opioids/People With Opioid Use Disorder (OUD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Interpersonal Attunement

  During Intervention

• Opioid Craving

  Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up

• Opioid Use

  Pre-Intervention, and 1 month Follow-Up

• Severity of Pain

  Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up

• Affect

  Pre-Intervention, during Intervention, and immediately post-Intervention.

Study Arms (2)

Meditation

EXPERIMENTAL

20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.

Behavioral: Meditation

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation about opioid neuropharmacology.

Behavioral: Psychoeducation

Interventions

Meditation BEHAVIORAL

20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.

Meditation

Psychoeducation BEHAVIORAL

20 minute psychoeducational script on the impact of opioid use on the brain.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive Impairment that would preclude participation in the research protocol
• Active suicidal intent or psychosis

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eric Garland, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Kroh, BS

CONTACT

619-259-0735; l1kroh@health.ucsd.edu

Kelly Hendrickson, MS

CONTACT

kehendrickson@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 4, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Data will be made available upon reasonable request with a signed data access agreement.

Locations

US (1)