Optimal Treatment of Veterans with PTSD and Comorbid Opiate Use Disorder (OUD)

患有 PTSD 和共病阿片类药物使用障碍 (OUD) 的退伍军人的最佳治疗

• 批准号: 9768142
• 负责人: ISMENE L. PETRAKIS
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768142
• 关键词: Abstinence; Address; Affect; Awareness; Back; Behavior Therapy; Buprenorphine; Caring; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials; Cognitive; Cognitive Therapy; Comorbidity; Conflict (Psychology); Control Groups; Counseling; DSM-V; Department of Defense; Dependence; Development; Diagnosis; Disease; Dose; Drug usage; Epidemic; Etiology; Evaluation; Evidence based treatment; General Population; Gold; Health Professional; Health Surveys; Heroin; Iatrogenesis; Incidence; Individual; Internet; Knowledge; Lead; Maintenance; Manuals; Measures; Mental Health; Mental disorders; Military Personnel; Numeric Rating Scale; Opiate Addiction; Opioid; Opioid agonist; Opioid replacement therapy; Pain Threshold; Pain intensity; Pain management; Pattern; Performance; Pharmaceutical Preparations; Phase; Physicians; Post-Traumatic Stress Disorders; Practice Guidelines; Predisposition; Psychotherapy; Public Health; Randomized; Randomized Controlled Trials; Readiness; Reporting; Severities; Sleep; Sleep disturbances; Sleeplessness; Street Drugs; Substance Use Disorder; Symptoms; Testing; TimeLine; Toxicology; Trauma; Treatment Effectiveness; Treatment Efficacy; United States; United States Department of Veterans Affairs; Urine; Veterans; Work; acute traumatic stress disorder; addiction; adverse outcome; base; buprenorphine treatment; chronic pain; effective intervention; effective therapy; evidence base; experience; follow-up; functional disability; heroin overdose; heroin use; high risk behavior; indexing; open label; opioid epidemic; opioid use; opioid use disorder; optimal treatments; overdose death; prescription opioid; program dissemination; psychoeducation; psychosocial; side effect; standard care; standard of care; symptom management; symptom treatment; treatment as usual; treatment group

Post-traumatic stress disorder (PTSD) is a serious disorder among Veterans and affects up to 20 % of Veterans from the recent conflicts. Given the high incidence of PTSD among Veterans, the US Department of Veterans Affairs (VA) and Department of Defense (DoD) have made the treatment of PTSD a priority. Cognitive Processing Therapy (CPT, CPT-C) is one of the standard evidence based therapies for PTSD and was rolled out nationally in a large dissemination project by the VA and the DoD as one of the gold standard treatments for PTSD. Recently the VA DoD Clinical Practice Guidelines on the Management of PTSD and Acute Stress Reaction (2017) have stated that individual trauma focused therapies should be the first line of treatment. Despite the effort in rolling out evidence based therapy, there is a lack of knowledge of the efficacy of these interventions in veterans with comorbid disorders. There is considerable evidence showing that PTSD is often comorbid with other substance use disorders including opioid dependence. Opioid use disorder (OUD) is a well-documented epidemic among the general population, and also has had a significant effect on Veterans. While the etiology is unknown, it is possible that the incidence may be in part due to the overuse of highly addictive prescription opioids leading to iatrogenic opioid dependence and the development of addictive disorders. Recent evidence has clearly shown that prescription OUD can lead to dependence on street drugs such as heroin. Buprenorphine treatment is the established treatment for those with opiate use disorders; it is the recommended treatment for Veterans with OUD and its use is leading to larger number of Veterans maintained on buprenorphine. However, the efficacy of treatments for PTSD among those maintained on buprenorphine is unknown. The objective of this study is to test a standard psychotherapy for PTSD in Veterans who also suffer from OUD. Specifically, this study will test whether Cognitive Processing Therapy (CPT)-C is more effective in treating PTSD, compared to a control group (Individual Drug Counseling or IDC; which approximates treatment as usual), among Veterans with PTSD and comorbid OUD who are maintained on buprenorphine. Other objectives include effect on opiate use, treatment retention, side effects, pain tolerance and general functioning. This will be a randomized, open-label clinical trial. The study has three phases. In Phase one, the induction phase, all Veterans (n=160) will be started on 2 mg of buprenorphine. The dose of buprenorphine will be increased over 5-7 days; dose will be clinically determined. After the maintenance dose of buprenorphine is reached all Veterans will enter Phase two, the treatment phase. During this phase Veterans will be randomly assigned to CPT-C or standard IDC for 12 weeks. They will be seen weekly for psychotherapy and also regularly (weekly, then biweekly, then monthly) for buprenorphine management, symptom evaluation, and medication refill. After completing treatment Veterans will be referred to a buprenorphine clinic for ongoing care and will enter the Third phase of the study, the follow up. During this phase they will be seen 1 month and 3 months after the completion of treatment.

创伤后应激障碍 (PTSD) 是退伍军人中的一种严重疾病，影响高达 20% 的退伍军人 最近冲突中的退伍军人。鉴于退伍军人中创伤后应激障碍（PTSD）的高发病率，美国卫生部 退伍军人事务部（VA）和国防部（DoD）已将治疗创伤后应激障碍（PTSD）作为优先事项。认知的 加工疗法（CPT、CPT-C）是针对 PTSD 的标准循证疗法之一，已推出 在 VA 和 DoD 的一个大型传播项目中，作为黄金标准治疗方法之一在全国范围内进行 创伤后应激障碍。最近，退伍军人管理局发布了创伤后应激障碍 (PTSD) 和急性应激管理临床实践指南 Reaction (2017) 指出，针对个体创伤的治疗应该是第一线治疗。 尽管努力推出基于证据的治疗，但仍缺乏对其疗效的了解。 这些干预措施针对患有共病的退伍军人。 有大量证据表明，创伤后应激障碍 (PTSD) 常常与其他物质使用障碍共存 包括阿片类药物依赖。阿片类药物使用障碍 (OUD) 是一种有据可查的流行病 人口，也对退伍军人产生了重大影响。虽然病因尚不清楚，但有可能是 该现象的部分原因可能是过度使用高度成瘾的处方阿片类药物导致医源性 阿片类药物依赖和成瘾性疾病的发展。最近的证据清楚地表明 处方 OUD 可能导致对海洛因等街头毒品的依赖。 丁丙诺啡治疗是阿片类药物使用障碍患者的既定治疗方法；它是 建议对退伍军人进行 OUD 治疗，其使用可以维持更多的退伍军人 丁丙诺啡。然而，维持丁丙诺啡治疗 PTSD 的疗效尚不明确。 未知。 这项研究的目的是测试针对同样患有创伤后应激障碍的退伍军人的标准心理治疗 来自乌德。具体来说，本研究将测试认知加工疗法（CPT）-C是否更有效 与对照组（个体药物咨询或 IDC；近似值）相比，治疗 PTSD 的效果更好 治疗），患有 PTSD 和共病 OUD 并维持丁丙诺啡的退伍军人。 其他目标包括对阿片类药物使用的影响、治疗保留、副作用、疼痛耐受性和一般情况 发挥作用。 这将是一项随机、开放标签的临床试验。该研究分为三个阶段。在第一阶段， 在诱导阶段，所有退伍军人 (n=160) 将开始服用 2 毫克丁丙诺啡。丁丙诺啡的剂量 将在 5-7 天内增加；剂量将根据临床确定。维持剂量后 丁丙诺啡达到要求后，所有退伍军人都将进入第二阶段，即治疗阶段。在此阶段退伍军人 将被随机分配到 CPT-C 或标准 IDC，为期 12 周。他们将每周接受心理治疗 还定期（每周，然后每两周，然后每月）进行丁丙诺啡管理，症状 评估和药物补充。完成治疗后，退伍军人将被转介接受丁丙诺啡治疗 诊所进行持续护理，并将进入研究的第三阶段，即随访。在此阶段，他们将 治疗完成后1个月和3个月可见。