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临床试验/NCT05219825
NCT05219825招募中不适用

Breathwork-assisted Treatment for Cannabis Use Disorder: A Proof-of-concept Study

Elias Dakwar2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
2
主要终点
Safety of the breathing session

研究概览

简要总结

The purpose of this proof-of-concept study is to evaluate the safety, feasibility and acceptability of a breathwork workshop intervention in individuals with cannabis use disorder.

详细描述

This study will test a 1-week breathwork workshop for treatment-seeking adults with a diagnosis of cannabis use disorder. The intervention consists of an enhanced breathing session with evocative music to facilitate experiencing non-ordinary states of consciousness, in addition to brief therapeutic interventions based on Motivational Interviewing and Mindfulness-based Relapse Prevention (MBRP). The primary aim is to test the acceptability, feasibility and safety of enhanced breathwork in a therapeutic framework for cannabis use disorder. In addition, the investigators seek to understand the phenomenology of breathwork that may explain any change related to addictive behaviors, as well as biological changes that occur during the breathwork session through heart rate variability and electroencephalography.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-70 years of age
  • Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for active cannabis use disorder.
  • Seeking treatment for their cannabis use

排除标准

  • Meets DSM-V criteria for schizophrenia or any psychotic illness or any dissociative disorder (Dissociative identity disorder, Dissociative amnesia, Depersonalization/derealization disorder).
  • Active substance use disorder except for cannabis, nicotine, and caffeine.
  • History of severe withdrawal symptoms (i.e withdrawal seizures).
  • History of dementia, epilepsy or seizures, cardiac arrhythmia, pacemaker/defibrillator, heart failure, asthma, panic disorder and other respiratory illnesses (ie: COPD).

结局指标

主要结局

Safety of the breathing session

时间窗: 24 hours after the breathing session.

Occurrence of adverse effects through a self-reported questionnaire.

Acceptability of the breathwork session

时间窗: One week after the breathing session.

Acceptability of the breathwork intervention through self-reported questionnaires.

次要结局

  • Phenomenology of breathwork #2(Obtained 24 hours after the breathing session)
  • Heart Rate Variability(Measured during breathing session)
  • Change in Cue Reactivity(From baseline to 1 month after the breathing session.)
  • Change in Motivation to Quit(From baseline to 1 month after the breathing session.)
  • Change in cannabis use(From baseline to 1 month after the breathing session.)
  • Phenomenology of breathwork #1(24 hours after the breathing session)
  • Electroencephalographic changes(Measured during breathing session)

研究者

发起方
Elias Dakwar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elias Dakwar

Associate Professor of Clinical Psychiatry

New York State Psychiatric Institute

研究点 (2)

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