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临床试验/NCT07386769
NCT07386769招募中不适用

Interpersonal Brain Function in Opioid Use

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Neurophysiological synchrony

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Cognitive Impairment that would preclude participation in the research protocol
  • Active suicidal intent or psychosis

研究组 & 干预措施

Meditation

Experimental

20 minutes of guided meditation during the laboratory session involving mindfulness of breathing and lovingkindness practice.

干预措施: Meditation (Behavioral)

Psychoeducation

Active Comparator

Psychoeducation about opioid neuropharmacology.

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Neurophysiological synchrony

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Garland

Professor of Psychiatry

University of California, San Diego

研究点 (1)

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