Opioid Use Disorder And Role of Yoga as an Adjunct in Management: Trial of Effectiveness And Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Abstinence (Negative urine screening for opiates at each follow-up), pain-BPI (Brief Pain Inventory), craving-OCS (Opioid Craving Scale), endorphins, fMRI-BOLD responses in represent to a craving inducing visual cue.
研究概览
简要总结
The proposed research aims to test the effects and mechanisms of 6-month Yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study assessing abstinence (opiate negative urine test) at each follow-up, pain, craving, perceived stress, anxiety, quality of sleep, real-world social and work life adjustment and yoga-based mental attitude (gunas). The mechanisms of action of yoga in OUD are proposed to be investigated by assessing- reward circuit activation through fMRI, autonomic functions using Heart rate variability, Plasma Endorphin and Serum Cortisol. The wait-list control group shall continue the standard treatment alone. Hypotheses: Adding Yoga-based intervention to standard treatment will improve abstinence, pain, craving, anxiety, psychological stress, quality of sleep, real-world social and work life functioning and gunas in patients with OUD and there will be demonstrable increase in plasma endorphin levels and reduction in serum cortisol in them. There would also be demonstrable changes in activation of areas of the brain associated with craving in OUD (in response to visual cues related to opioid addiction). Adding yoga in withdrawal phase would reduce withdrawal symptoms and sympathetic arousal ( heart rate variability) with lesser requirement of buprenorphine to manage withdrawal phase than standard treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients meeting only with following criteria will be allowed to undergo the trail.
- •a) Diagnosis of OUD (Opioid Use Disorder) (DSM – V criteria) b) Score >3 on Clinical Global Impression – Severity (CGI-S) c) Age range: 18–50 years d) All gender e) Written informed consent f) Access to smart phone and internet.
排除标准
- •Patients meeting with following criteria will not be allowed to undergo the trail.
- •a) Prescription of OST (Opioid Substitution Therapy) other than Buprenorphine/naloxone b) Severe withdrawal symptoms (COWS>25) c) Other diseases causing intractable pain d) Prescription opioids for pain related to other medical conditions e) Co-morbid alcohol/BZD/Cannabis/Multiple substance dependence in last 6 months except nicotine f) Impaired intellectual functioning (HMSE<24) g) MRI contraindications such as claustrophobia, metal implants or paramagnetic objects in the body h) Neurosurgery/loss of consciousness due to head injury in past/diseases affecting Central Nervous System i) Severe psychiatric or medical illness preventing practice of yoga program j) Pregnancy or post-partum k) Harm-risk to self or others l) Current/ recent practice of yoga/meditation (>4hr/month in last 3-months).
结局指标
主要结局
Abstinence (Negative urine screening for opiates at each follow-up), pain-BPI (Brief Pain Inventory), craving-OCS (Opioid Craving Scale), endorphins, fMRI-BOLD responses in represent to a craving inducing visual cue.
时间窗: 15 days, 3 months, 6 months
次要结局
- Percentage of Abstinent Subjects, Maximum Consecutive Days of Abstinence, Self reported frequency of opioid-use, withdrawal symptoms-COWS (The Clinical Opiate Withdrawal Scale), severity-CGI (The Clinical Global Impressions Scale), Pain threshold-algometer, Stress-PSS (Perceived Stress Scale), Sleep-PSQI (The Pittsburgh Sleep Quality Index), Functioning-WSAS (The Work and Social Adjustment Scale), HRV (Heart Rate Variability),(Cortisol, Buprenorphine Dosage and Side-effects(UKU), and Vedic Personality Inventory(VPI) for Gunas.)