NCT03397212Unknown4 期
Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in intensity of withdrawal symptoms
研究概览
简要总结
This project aims at examining the following hypotheses:
- Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
- Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain patients treated with opioids over 3 months
- •The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
- •The patient is motivated for opioid withdrawal
- •The patient has experienced withdrawal symptoms
- •The patient must be able to understand, speak and write Danish
- •The patient must be able to transport himself to the pain center
排除标准
- •Children under 18 years old
- •External ear infection
- •Treatment with benzodiazepines.
- •Active substance abuse and alcohol abuse.
- •Contraindications for treatment with clonidine:
- •Bradyarrhythmias caused by diseased sinus cube or AV block of 2nd or 3rd grade.
- •lactose intolerance
- •Heart failure
- •High medullary damage
- •Cardiac conduction disturbances
- •Pregnancy and breastfeeding
研究组 & 干预措施
NADA and Clonidine
Experimental
NADA acupuncture and treatment with tbl Clonidine
干预措施: NADA acupuncture (Other)
Sham acupuncture and Clonidine
Sham Comparator
Sham ear acupuncture and treatment with tbl Clonidine
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Change in intensity of withdrawal symptoms
时间窗: 3 months and 1 year
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
次要结局
- Change in quality of life assessed with SF36(3 months and 1 year)
研究者
Romanas Polianskis
Principal investigator
Rigshospitalet, Denmark
研究点 (2)
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