A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal
研究概览
简要总结
This study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. One group will undergo the standard opioid weaning process and the other group will have the addition of the NADA Protocol to the weaning process.
详细描述
The NADA (National Acupuncture Detoxification Association) Protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). The NADA Protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation & recovery maintenance. It is also commonly used for PTSD and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain.
It is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. Given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Adults aged 18 and older
- •Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.
排除标准
- 未提供
研究组 & 干预措施
Medication management & NADA Protocol
Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly
干预措施: NADA Protocol (Procedure)
Medication management & NADA Protocol
Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly
干预措施: Medication management (Other)
Medication management
Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens.
干预措施: Medication management (Other)
结局指标
主要结局
Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal
时间窗: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
次要结局
- Time to cessation of opioids(time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months))
- Off-opioids rate(time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months))
- Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS)(9 months)
研究者
Heather Jackson
Assistant in Anesthesiology
Vanderbilt University Medical Center