Efficacy of Integrated Yoga Therapy in Opium Abuse Recovery: A longitudinal randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Abstinence: Proportion of participants with opioid-negative urine tests at 3 months and 6 months post-intervention.
研究概览
简要总结
Globally, over 35 million people suffer from substance use disorders, with opioids, including opium, contributing to approximately 500,000 deaths annually, including 80,000 from respiratory depression in the US alone (WHO). In India, 22.6 million individuals need treatment for substance abuse, with Western Rajasthan reporting high opium addiction rates (up to 8.4% in Barmer) (National Survey). Opium addiction causes cognitive decline, hypogonadism, respiratory depression, insomnia, QT prolongation, and osteopenia/osteoporosis, severely impacting overall health and socio-economic stability. This urgent study addresses the escalating opium addiction crisis in rural India, where conventional treatments show limited success. By leveraging Integrated Yoga Therapy (IYT) comprising Shatkarma, Sukshma and sthula vyayama, asana, pranayama, and meditation, a culturally resonant and cost-effective intervention, it aims to mitigate severe health complications, reduce relapse, and enhance recovery, potentially shaping scalable addiction treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •a) Diagnosis of OUD (DSM 5 criteria) b) Score greater than 3 on Clinical Global Impression Severity (CGIS) c) Age range 18 to 60 years d) Male e) Written informed consent f) Geographical Location Residents of rural western Rajasthan.
排除标准
- •a) Severe withdrawal symptoms (COWS greater than 25) b) other diseases causing intractable pain.
- •c) Prescription opioids for pain related to her medical conditions d) Comorbid alcohol, benzodiazepine, cannabis, etc., multiple substance dependence in last six months except for nicotine e) Impaired intellectual functioning (HMSE more than 24) f) Severe psychiatric or medical illness preventing practice of the yoga program g) Risk of harm to self or others h) Current or recent practice of yoga (more than 4hr per month in last three months).
结局指标
主要结局
Abstinence: Proportion of participants with opioid-negative urine tests at 3 months and 6 months post-intervention.
时间窗: Baseline - 3 Months and 6 Months
Craving: Change in scores on the Craving Questionnaire (CCQ) from baseline to 3
时间窗: Baseline - 3 Months and 6 Months
months and 6 months.
时间窗: Baseline - 3 Months and 6 Months
次要结局
- Psychological Well-being: Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Depression Anxiety Stress Scales - Short Form (DASS-21), World Health Organization Quality of Life - BREF(WHOQOL-BREF), Beck Hopelessness Scale (BHS), Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2).(Baseline - 3 Months and 6 Months)
- Physiological Health: Heart Rate Variability (HRV), spirometry, Gut Dysmotility Questionnaire (GDQ), Constipation Scoring System (CSS), Bristol Stool(Form Scale (BSFS), o Patient Assessment of Constipation-Symptoms (PAC-SYM), o Bowel Function Index (BFI))
- Biochemical markers: cortisol, beta-endorphins, osteocalcin, prolactin,(luteinizing hormone (LH), testosterone, dopamine, serotonin, adrenocorticotropic hormone (ACTH), and routine serum markers.)
- Sensory Function Recovery: Tinnitus Handicap Inventory, Taste Strips Test, Chemosensory Questionnaire (CPQ), Quality of Vision (QoV) Questionnaire.
- Withdrawal Symptoms and Adverse Effects: Clinical Opiate Withdrawal Scale (COWS), Udvalg for(Kliniske Undersogeleser (UKU) Side Effects Rating Scale.)
- Behavioral and Cognitive Enhancement: Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index, Buss-Perry Aggression Scale (BPAQ), cognitive tests (Five-Point(Test, Digit Span, Spatial Span, Stroop Color-Word Interference Test, Game)
- Sustainability of Therapeutic Benefits: : Relapse rates defined as return to opioid use, confirmed(by urine drug screens or self-reported via Time-Line Follow Back (TLFB).)
研究者
Sanjib Patra
Central University of Rajasthan