跳至主要内容
临床试验/CTRI/2026/04/108925
CTRI/2026/04/108925尚未招募1/2 期

Effect of single session heart rate variability biofeedback on autonomic and cognitive function in patients with opioid use disorder: A pilot study

AIIMS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月14日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
AIIMS
入组人数
30
试验地点
1

研究概览

简要总结

OUD is characterized by dysregulation of the brain’s reward system, including the mesolimbic dopamine pathway, prefrontal cortex, and amygdala. Its association with maladaptive neuromodulation affecting executive function, emotional regulation, and stress responses, contributes to disease pathophysiological features like craving, relapse and cognitive effects. Studies show positive correlation between stressful life events and high probability of relapse, highlighting the need for stress management techniques that can address the need based acute management of stress at the incidence of high stress life events. Studies have shown that HRV Biofeedback can reduce stress and improve emotional and cognitive functions in healthy subjects.Therefore, the present pilot randomized controlled trial is planned to study the effect of single session HRV Biofeedback training on the autonomic and cognitive function, stress, craving and withdrawal in patients of OUD during early agonist detoxification. The results of the present study can be useful in the determining the role of HRV Biofeedback as an adjunct to the main treatment strategy to support recovery by helping acute management of stressful life events which otherwise are the precipitators of relapse.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • Subjects with addictive disorders for duration of at least 12 months as diagnosed by DSM-5 criteria
  • less than 7 days of initiation of buprenorphine therapy
  • Right-handed subjects
  • Subject able to perform computer task.
  • Could give informed consent.

排除标准

  • H/o any psychiatric disease other than substance related and addictive disorder
  • H/o any neurological disorder
  • Chronic physical illnesses (excluded based on clinical history)
  • HIV seropositivity
  • H/o colour blindness.

研究者

发起方
AIIMS
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Akanksha Singh

All India Institute of Medical Sciences

研究点 (1)

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