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Recruiting NCT07386769

Interpersonal Brain Function in Opioid Use

No phase Interventional People Who Use Opioids/People With Opioid Use Disorder (OUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meditation, Psychoeducation.
Who it may be relevant to
Registry conditions: People Who Use Opioids/People With Opioid Use Disorder (OUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Meditation
    20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
  • Behavioral Psychoeducation
    20 minute psychoeducational script on the impact of opioid use on the brain.

Primary outcome measures

  • Neurophysiological synchrony [Time frame: During the intervention and for 5 minutes afterwards]
Secondary outcome measures (9)
  • Interpersonal Attunement [Time frame: During Intervention]
  • Opioid Craving [Time frame: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up]
  • Opioid Use [Time frame: Pre-Intervention, and 1 month Follow-Up]
  • Severity of Pain [Time frame: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up]
  • Affect [Time frame: Pre-Intervention, during Intervention, and immediately post-Intervention.]
  • State Self-Transcendence [Time frame: Pre-Intervention, during Intervention, immediately post-Intervention.]
  • Metacognitive processes [Time frame: Pre-Intervention, during Intervention, and immediately post-Intervention.]
  • Cardiac-autonomic synchrony [Time frame: During the intervention and for 5 minutes afterwards]
  • Facial expression synchrony [Time frame: During the intervention and for 5 minutes afterwards]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of California, San Diego — La Jolla

Identifiers

NCT: NCT07386769 · 813632

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗