Bhargav Hemant, Holla Bharath, Mahadevan Jayant, Jasti Nishitha, Philip Mariamma, Sharma Priyamvada, A Vedamurthachar, Meherwan Mehta Urvakhsh, Varambally Shivarama, Venkatasubramanian Ganesan, Chand Prabhat, Bn Gangadhar, Hill Kevin P, Bolo Nicolas R, Keshavan Matcheri, Murthy Pratima
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, 560029, India.
Centre for Addiction Medicine, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, 560029, India.
Wellcome Open Res. 2024 Jan 3;9:4. doi: 10.12688/wellcomeopenres.19392.1. eCollection 2024.
The proposed research aims to test the effects and mechanisms of a six-month yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study with the following primary outcome variables: 1) clinical: abstinence (opioid negative urine test), and reductions in pain and craving, and 2) mechanisms: reward circuit activation in response to opioid visual cue craving paradigm, activation in response to a cognitive control task, and resting state functional connectivity through fMRI, and plasma beta-endorphin levels. Secondary outcome variables are perceived stress, anxiety, sleep quality, cognitive performance, pain threshold, buprenorphine dosage and side effects, withdrawal symptoms, socio-occupational functioning, vedic personality traits, heart rate variability, serum cortisol, and brain GABA levels through magnetic resonance spectroscopy (MRS).
In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 164 patients with OUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (standard treatment + yoga-based intervention), or waitlist group (standard treatment alone). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized yoga program for OUD will be used as an intervention. Participants in the yoga arm will receive 10 supervised in-person sessions of yoga in the initial two weeks followed by tele-yoga sessions thrice a week for the next 22 weeks. The wait-list control group will continue the standard treatment alone for 24 weeks. Assessments will be done at baseline, two weeks, 12 weeks, and 24 weeks. Data from all randomized subjects will be analysed using intent-to-treat analysis and mixed model multivariate analysis.
Findings will be disseminated through peer-reviewed publication, conference presentations, and social media.
The trial has been registered under Clinical Trials Registry-India with registration number CTRI/2023/03/050737.
拟开展的研究旨在通过一项随机对照研究，以如下主要结局变量来测试为期六个月的瑜伽干预作为阿片类物质使用障碍（OUD）标准治疗补充措施的效果及机制：1）临床指标：戒断（阿片类物质尿液检测呈阴性）、疼痛减轻和渴望减少；2）机制指标：对阿片类物质视觉线索渴望范式的奖励回路激活、对认知控制任务的激活，以及通过功能磁共振成像（fMRI）测量的静息态功能连接，和血浆β-内啡肽水平。次要结局变量包括感知压力、焦虑、睡眠质量、认知表现、疼痛阈值、丁丙诺啡剂量及副作用、戒断症状、社会职业功能、吠陀人格特质、心率变异性、血清皮质醇，以及通过磁共振波谱（MRS）测量的脑内γ-氨基丁酸（GABA）水平。
在这项单盲、随机、对照、平行组优效性试验中，分配比例为1:1，164名在印度一家三级精神卫生保健医院接受门诊/住院临床服务的OUD患者在获得知情同意后将被纳入研究。连续同意参与的患者将被随机分配到两组之一——瑜伽组（标准治疗 + 基于瑜伽的干预）或等待列表组（仅接受标准治疗）。将采用分配隐藏，临床医生、结局评估者和数据分析人员将对受试者分组情况保持盲态。一项经过验证和标准化的针对OUD的瑜伽项目将用作干预措施。瑜伽组的参与者将在最初两周接受10次有监督的现场瑜伽课程，随后在接下来的22周内每周进行三次远程瑜伽课程。等待列表对照组将仅继续接受24周的标准治疗。将在基线、两周、12周和24周进行评估。来自所有随机分组受试者的数据将采用意向性分析和混合模型多变量分析进行分析。
研究结果将通过同行评审出版物、会议报告和社交媒体进行传播。
该试验已在印度临床试验注册中心注册，注册号为CTRI/2023/03/050737。
