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Interpersonal Brain Function in Opioid Use

Interpersonal Brain Function in Opioid Use

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07386769
Enrollment
60
Registered
2026-02-04
Start date
2026-02-02
Completion date
2027-05-01
Last updated
2026-02-04

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

Conditions

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

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.

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.

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Neurophysiological synchronyDuring the intervention and for 5 minutes afterwardsDyadic 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.

Secondary

MeasureTime frameDescription
Interpersonal AttunementDuring InterventionInterpersonal 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).
Opioid CravingPre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-upOpioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).
Opioid UsePre-Intervention, and 1 month Follow-UpDays of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.
Severity of PainPre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-upPain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
AffectPre-Intervention, during Intervention, and immediately post-Intervention.Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).
State Self-TranscendencePre-Intervention, during Intervention, immediately post-Intervention.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
Metacognitive processesPre-Intervention, during Intervention, and immediately post-Intervention.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.
Cardiac-autonomic synchronyDuring the intervention and for 5 minutes afterwardsCardiac-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.
Facial expression synchronyDuring the intervention and for 5 minutes afterwardsFacial 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

Countries

United States

Contacts

CONTACTLori Kroh, BS
l1kroh@health.ucsd.edu619-259-0735
CONTACTKelly Hendrickson, MS
kehendrickson@health.ucsd.edu
PRINCIPAL_INVESTIGATOREric Garland, PhD

University of California, San Diego

Outcome results

None listed

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