CClinicalTrials.gg
RecruitingNCT07386769Updated Feb 4, 2026

Interpersonal Brain Function in Opioid Use

An interventional study of Meditation and Psychoeducation in People Who Use Opioids/People With Opioid Use Disorder (OUD), sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • People Who Use Opioids/People With Opioid Use Disorder (OUD)
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Cognitive Impairment that would preclude participation in the research protocol
  2. Active suicidal intent or psychosis
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Meditation

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

    Behavioral: Meditation

  • Active comparator
    Psychoeducation

    Psychoeducation about opioid neuropharmacology.

    Behavioral: Psychoeducation

Interventions

  • BehavioralMeditation

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

  • BehavioralPsychoeducation

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

06

What researchers measure

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.

    Time frame: During the intervention and for 5 minutes afterwards

Secondary outcomes

  1. 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).

    Time frame: During Intervention

  2. Opioid Craving

    Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).

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

  3. Opioid Use

    Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.

    Time frame: Pre-Intervention, and 1 month Follow-Up

  4. Severity of Pain

    Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)

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

  5. Affect

    Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).

    Time frame: Pre-Intervention, during Intervention, and immediately post-Intervention.

  6. 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

    Time frame: Pre-Intervention, during Intervention, immediately post-Intervention.

  7. 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.

    Time frame: Pre-Intervention, during Intervention, and immediately post-Intervention.

  8. 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.

    Time frame: During the intervention and for 5 minutes afterwards

  9. 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

    Time frame: During the intervention and for 5 minutes afterwards

07

Study locations

1 of 1 sites recruiting
  • University of California, San Diego
    La Jolla, California 92093, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07386769
Lead sponsor
University of California, San Diego
Responsible party
Eric Garland (Professor of Psychiatry, University of California, San Diego) — Principal investigator
First posted
Feb 4, 2026
Start date
Feb 2, 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Feb 4, 2026

Study contacts

Lori Kroh, BS
Contact
l1kroh@health.ucsd.edu
619-259-0735
Kelly Hendrickson, MS
Contact
kehendrickson@health.ucsd.edu
Eric Garland, PhD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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