Medical Strategies for the Management of Pain in the Addicted Patient

治疗成瘾患者疼痛的医疗策略

• 批准号: 8272535
• 负责人: RICHARD D BLONDELL
• 金额: $ 7.93万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-15 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8272535
• 关键词: Address; Alcohol or Other Drugs use; Analgesics; Back; Behavior; Behavior Therapy; Behavioral; Buffaloes; Buprenorphine; Caring; Case Series; Case Study; Chemicals; Chronic; Chronic low back pain; Client; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical effectiveness; Communities; Community Practice; Consent; Continuity of Patient Care; Counseling; Data; Dependency; Development; Diagnosis; Dose; Drug Addiction; Drug Metabolic Detoxication; Drug usage; Evidence based treatment; Expert Opinion; Functional disorder; Future; Guidelines; Health Services; Human Resources; Hydrocodone; Illicit Drugs; Inpatients; Logistics; Mainstreaming; Measures; Medical; Medicine; Methadone; Mood Disorders; Naloxone; Operative Surgical Procedures; Opiate Addiction; Opioid; Opioid Analgesics; Opioid Rotation; Outcome; Outpatients; Overdose; Oxycodone; Pain; Pain management; Participant; Patients; Pharmaceutical Preparations; Physicians; Primary Care Physician; Primary Health Care; Provider; Quality of life; Rehabilitation therapy; Relative (related person); Reporting; Research; Research Support; Safety; Services; Supervision; Syndrome; Techniques; Testing; Time; Toxicology; United States; Urine; Vertebral column; active comparator; addiction; base; chronic back pain; chronic pain; comparative effectiveness; diaries; drug quality; experience; medical specialties; meetings; methadone maintenance; non-cancer pain; patient population; prescription opioid; prescription opioid abuse; programs; psychosocial; randomized trial; treatment program; trial comparing

DESCRIPTION (provided by applicant): A substantial portion of primary care patients being treated with short-acting opioids for chronic non- cancer pain also develop opioid dependence, and their addiction often worsens with continued use of these drugs. Non-opioid medications frequently are inadequate for pain control in these patients, and physicians have limited options for referring them to substance use treatment. Many physicians, therefore, have tried a middle-ground approach of switching these patients to the long-acting opioids methadone and buprenorphine, which have analgesic effects but lower potential for exacerbating addiction. Experience with this has been encouraging, but the evidence is largely anecdotal and research is needed to help guide clinicians in making evidence-based treatment decisions for this growing patient population. The purpose of this pilot randomized trial is to compare methadone and buprenorphine for pain control and other clinical outcomes in patients with chronic pain and coexisting addiction. Primary care physicians at 6 community practices in Buffalo, NY, will refer 66 patients who have objective evidence to support the diagnosis of a chronic non-cancer pain condition related to the spine following a surgical procedure (i.e., "failed back syndrome") and who also have an addiction to prescription opioids. Consenting participants will be assigned to one of two treatment conditions: 1) methadone 30-60 mg per day in divided doses (active comparator) or 2) sublingual buprenorphine 4-16 mg per day in divided doses (experimental group). All participants will also be referred for behavioral therapy. The patients will receive the medications for 6 months at an outpatient center under the supervision of a board-certified Addiction Medicine physician. During that time they will keep a "treatment diary" in which they use established assessment measures to record daily pain levels, and they will have monthly face-to-face meetings with study personnel to gather additional information, including use of other drugs, quality of life, attendance at behavioral counseling, overall level of function, and urine toxicology. Patients will then return to their original primary care providers for ongoing pain management, under arrangements with the study Addiction Medicine physician. Final data will be collected at the nine-month point to assess pain and other outcomes, including whether patients have remained in treatment. Study findings will provide preliminary but important clinical guidance on the use of buprenorphine versus methadone for patients with chronic pain and coexistent addiction. Buprenorphine has a good safety profile, so if it is found to be at least as clinically effective as methadone, this would constitute a valuable contribution to evidence-based treatment decisions. The findings also will contribute to subsequent research supporting development of clinical guidelines. The ultimate impact would be a paradigm shift from limited specialty options to mainstream medical management so patients with chronic pain and coexistent addiction could be treated in a manner similar to those with other chronic conditions.

描述（由申请人提供）：大部分的初级保健患者接受了慢性非癌症疼痛的短效阿片类药物治疗也会发展出阿片类药物的依赖性，并且由于继续使用这些药物，他们的成瘾经常恶化。这些患者的非阿片类药物经常无法控制疼痛，并且医生将其转介给药物使用治疗的选择有限。因此，许多医生尝试过将这些患者切换为长效阿片类美沙酮和丁丙诺啡的中间地面方法，它们具有镇痛作用，但较低的加剧成瘾的潜力。有这种经验令人鼓舞，但是证据在很大程度上是轶事，需要进行研究以帮助临床医生为这一不断增长的患者人群做出基于证据的治疗决策。 该试验随机试验的目的是比较美沙酮和丁丙诺啡的疼痛控制和其他慢性疼痛和共存患者的临床结局。纽约州布法罗市6种社区实践的初级保健医生将参考66例具有客观证据的患者，以支持与手术程序后与脊柱相关的慢性非癌症疼痛疾病的诊断（即“失败的背部综合症”），并且对处方药的成瘾也有成瘾。同意参与者将分配给两种治疗条件之一：1）美沙酮每天30-60 mg（主动比较者）或2）舌下丁丙诺啡每天4-16毫克的分裂剂量（实验组）。所有参与者也将被转介进行行为疗法。在经过董事会认证的成瘾医学医师的监督下，患者将在门诊中心接受6个月的药物。在此期间，他们将保留“治疗日记”，其中使用既定的评估措施来记录每日疼痛水平，并且他们将每月与研究人员进行面对面的会议，以收集其他信息，包括使用其他药物，生活质量，行为咨询，整体功能水平以及尿液毒理学。然后，在与研究成瘾医学医师的安排下，患者将返回其原始的初级保健提供者进行持续的疼痛管理。最终数据将在9个月的时间收集，以评估疼痛和其他结果，包括患者是否仍在治疗中。 研究结果将为慢性疼痛和共存的患者提供有关丁丙诺啡与美沙酮使用的初步但重要的临床指导。丁丙诺啡具有良好的安全性，因此，如果发现至少与美沙酮一样有效，这将构成对循证治疗决策的宝贵贡献。这些发现还将有助于随后的研究支持临床准则的制定。最终的影响是从有限的专业选择到主流医疗管理的范式转变，因此可以以类似于其他慢性病患者的方式对患有慢性疼痛和共存成瘾的患者进行治疗。