University of California, San Diego
La Jolla, California, 92093, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07386769
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Cognitive Impairment that would preclude participation in the research protocol
- Active suicidal intent or psychosis
Treatment and study plan
Meditation
Behavioral20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
Psychoeducation
Behavioral20 minute psychoeducational script on the impact of opioid use on the brain.
Primary outcomes
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Neurophysiological synchrony
Time frame: During the intervention and for 5 minutes afterwards
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.
Secondary outcomes
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Interpersonal Attunement
Time frame: During Intervention
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).
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Opioid Craving
Time frame: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).
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Opioid Use
Time frame: Pre-Intervention, and 1 month Follow-Up
Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.
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Severity of Pain
Time frame: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
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Affect
Time frame: Pre-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).
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State Self-Transcendence
Time frame: Pre-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
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Metacognitive processes
Time frame: Pre-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.
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Cardiac-autonomic synchrony
Time frame: During the intervention and for 5 minutes afterwards
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.
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Facial expression synchrony
Time frame: During the intervention and for 5 minutes afterwards
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
Study contacts
Contact information is provided by the study sponsor or research team.
Kelly Hendrickson, MS
CONTACT
Lori Kroh, BS
CONTACT
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 4, 2026
- Registry last updated
- Feb 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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