Effect of a validated yoga intervention on cognitive functions in patients with opioid use disorder - a randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Stop signal task.
研究概览
简要总结
Patients diagnosed with opioid use disorder are assessed for severity of withdrawal symptoms using Clinical Opiate Withdrawal Scale (COWS). The patients with mild to moderate severity of withdrawal symptoms and taking buprenorphine for management of symptoms are randomized into two groups that is intervention group Yoga + standard treatment group and control group Treatment as usual + Interactive health education and stretching exercises. Duration of intervention is 24 weeks. Clinical history will be done at baseline. Assessments will be done at the baseline, 3 months and 6 months. An interview will be done at the end of 1 year to assess relapse and frequency of opioid use. Safety assessments and adverse events will be monitored and appropriately documented for the duration of study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Opioid use disorder.
- •Subjects with mild to moderate severity of withdrawal symptoms (Clinical Opiate Withdrawal Scale: COWS score below 24).
- •Subjects who got admitted into CAM, NIMHANS, and started treatment with Buprenorphine.
- •Age range: 18 to 45 years.
- •Both genders.
- •Written informed consent.
排除标准
- •COWS score more than
- •Patients not willing to give informed consent.
- •History of current medical illness that may significantly affect brain functions.
- •Patients with intractable pain due to other diseases and those on prescribed opioids for the pain of other medical conditions.
- •Impaired general intellectual functioning (Mini-Mental Status Exam, MMSE below 24).
- •Past history of head injury or concomitant severe medical conditions.
- •With co-morbid (alcohol/benzodiazepine/cannabis or multiple) substance dependence except nicotine.
- •Subjects who had received specific yoga practices for OUD in the past.
- •Pregnant or post-partum subjects.
结局指标
主要结局
Stop signal task.
时间窗: Baseline, 3 months, 6 months and 12 months
Number and Frequency of Relapsing episodes.
时间窗: Baseline, 3 months, 6 months and 12 months
次要结局
- Clinical Opiate Withdrawal Scale (COWS)(Digit Span Test (DST) - Forward and Backward)
研究者
Dr Suddala Goutham
National Institute of Mental Health and Neuroscience.