Interpersonal Brain Function in Opioid Use

January 29, 2026 updated by: Eric Garland, University of California, San Diego
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California, San Diego
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Meditation
20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
Behavioral: Meditation
20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
Active Comparator: Psychoeducation
Psychoeducation about opioid neuropharmacology.
Behavioral: Psychoeducation
20 minute psychoeducational script on the impact of opioid use on the brain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the intervention and for 5 minutes afterwards

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
During Intervention
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).
Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
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.
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
Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
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).
Pre-Intervention, during Intervention, and immediately post-Intervention.
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
Pre-Intervention, during Intervention, immediately post-Intervention.
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.
Pre-Intervention, during Intervention, and immediately post-Intervention.
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.
During the intervention and for 5 minutes afterwards
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
During the intervention and for 5 minutes afterwards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Garland, PhD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 813632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will become available after the publication of the main study findings from the final data set. Data will be made permanently available.

IPD Sharing Access Criteria

Data will be made available upon reasonable request with a signed data access agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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