People Who Use Opioids/People With Opioid Use Disorder (OUD)NCT07386769
Interpersonal Brain Function in Opioid Use
A study testing Meditation and Psychoeducation in people with People Who Use Opioids/People With Opioid Use Disorder (OUD), run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- People Who Use Opioids/People With Opioid Use Disorder (OUD)
- What is being tested?
- Meditation and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive Impairment that would preclude participation in the research protocol
- Active suicidal intent or psychosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Hendrickson, MS contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Eric Garland, PhD, 858-822-4092, egarland@health.ucsd.edu
About this study
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.
- Being tested
- Meditation, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.
PsychoeducationBehavioural
20 minute psychoeducational script on the impact of opioid use on the brain.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | 20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice. Receives: Behavioral: Meditation |
| Psychoeducation | Active comparator | Psychoeducation about opioid neuropharmacology. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intervention and for 5 minutes afterwards
Secondary outcomes (9)
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).
Measured: During Intervention
Opioid Craving
Opioid craving measured by 0-10 numeric rating scale (0=no craving, 10=extreme craving).
Measured: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Opioid Use
Days of opioid use measured by the Timeline Followback Interview and completion of a urine drug toxicology screen.
Measured: Pre-Intervention, and 1 month Follow-Up
Severity of Pain
Pain rating measured by scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Measured: Pre-Intervention, during Intervention, immediately post-Intervention, and at 1 month follow-up
Affect
Positive and negative affect measured on a 0-10 numeric rating scale (0=low affect, 10=very high affect).
Measured: Pre-Intervention, during Intervention, and immediately post-Intervention.
State Self-Transcendence
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
Measured: Pre-Intervention, during Intervention, immediately post-Intervention.
Metacognitive processes
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.
Measured: Pre-Intervention, during Intervention, and immediately post-Intervention.
Cardiac-autonomic synchrony
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.
Measured: During the intervention and for 5 minutes afterwards
Facial expression synchrony
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
Measured: During the intervention and for 5 minutes afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People Who Use Opioids/People With Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of California, San Diego
- Investigators
- Eric Garland, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386769
- Sponsor's protocol ID
- 813632
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Brain Function in Opioid Use
- ClinicalTrials.gov ID
- NCT07386769
- Acronym / sponsor ID
- 813632
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: Meditation20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsychoeducation about opioid neuropharmacology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive Impairment that would preclude participation in the research protocol
- Active suicidal intent or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice. | Behavioural | Meditation |
| Psychoeducation20 minute psychoeducational script on the impact of opioid use on the brain. | Behavioural | Psychoeducation |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Hendrickson, MS contact
Eric Garland, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and Psychoeducation in people with People Who Use Opioids/People With Opioid Use Disorder (OUD), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Kroh, BS (619-259-0735, l1kroh@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiological synchrony (time frame: During the intervention and for 5 minutes afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.