Interpersonal Brain Function in Opioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cognitive Impairment that would preclude participation in the research protocol
Active suicidal intent or psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MeditationExperimental treatment 1 intervention
Group B: PsychoeducationActive comparator 1 intervention
Trial outcomes
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 afterwardsSecondary 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 Intervention2
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-up3
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-Up4
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-upSponsors and contacts
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Source ClinicalTrials.gov