Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Buprenorphine Tolerability
研究概览
简要总结
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) "accelerated" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.
详细描述
With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Arm 1 open label, double blind procedures for randomization of BUP and TMS
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
open label BUP
干预措施: Buprenorphine Patch (Drug)
Real vs Placebo BUP
干预措施: Buprenorphine Patch (Drug)
Real vs Placebo BUP
干预措施: Placebo (Drug)
Real vs Sham TMS
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
Real vs Sham TMS
干预措施: Sham Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
Buprenorphine Tolerability
时间窗: up to Day-13
Tolerability of open-label transdermal buprenorphine. Buprenorphine tolerability defined as the proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.
Pain Severity -with Buprenorphine Patch
时间窗: up to Day-20
Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "usual," "now," range 0-10) with a higher score being worse.
次要结局
- Buprenorphine Transition Rate(Day-20)
- Quality of Life -with Buprenorphine Patch(up to Day-20)
研究者
Kelly Barth
Professor-Faculty
Medical University of South Carolina