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: 9979789
• 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/9979789
• 关键词: Abstinence; Address; Affect; Awareness; Back; Behavior Therapy; Buprenorphine; Caring; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials; Cognitive; Cognitive Therapy; 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; comorbidity; 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障碍，影响多达20%的 最近冲突中的退伍军人。鉴于退伍军人中创伤后应激障碍的高发病率，美国国防部 退伍军人事务部(VA)和国防部(DoD)已将创伤后应激障碍的治疗列为优先事项。认知 过程疗法(CPT，CPT-C)是创伤后应激障碍的标准循证疗法之一，并已推广 退伍军人事务部和国防部在全国范围内开展的一项大型传播项目，将其作为治疗 创伤后应激障碍。最近，退伍军人事务部关于处理创伤后应激障碍和急性应激反应的临床实践指南 《反应》(2017)指出，以个人创伤为重点的治疗应是一线治疗。 尽管在推出循证疗法方面做出了努力，但对其疗效缺乏了解 这些干预措施适用于患有共病障碍的退伍军人。 有相当多的证据表明，创伤后应激障碍常常与其他物质使用障碍并存。 包括阿片类药物依赖。阿片类药物使用障碍(OUD)是一种在普通人群中流行的有充分证据的流行病 人口，也对退伍军人产生了重大影响。虽然病因不明，但有可能是 发生这种情况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 阿片类药物依赖与成瘾障碍的发展。最近的证据清楚地表明， 处方可能会导致对海洛因等街头毒品的依赖。 丁丙诺啡治疗是治疗阿片类药物使用障碍的既定疗法；它是 退伍军人OUD的推荐治疗及其使用导致了更多的退伍军人得到维持 丁丙诺啡。然而，丁丙诺啡维持治疗的创伤后应激障碍的疗效是 未知。 这项研究的目的是测试一种标准的心理疗法，用于治疗遭受创伤后应激障碍的退伍军人 来自乌德。具体地说，这项研究将测试认知加工疗法(CPT)-C是否更有效 在治疗创伤后应激障碍方面，与对照组(个体药物咨询或IDC；这与 在患有创伤后应激障碍和合并症的退伍军人中，使用丁丙诺啡维持治疗)。 其他目标包括影响鸦片类药物的使用、治疗保留、副作用、疼痛耐受性和一般情况。 功能正常。 这将是一项随机、开放标签的临床试验。这项研究分为三个阶段。在第一阶段， 在诱导期，所有退伍军人(n=160)将开始注射丁丙诺啡2 mg。丁丙诺啡的剂量 将在5-7天内增加；剂量将由临床确定。在维持量后 丁丙诺啡达到后，所有退伍军人将进入第二阶段，治疗阶段。在这一阶段，退伍军人 将随机分配到CPT-C或标准IDC，为期12周。他们将每周接受心理治疗 也定期(每周，然后每两周，然后每月)丁丙诺啡治疗，症状 评估，并补充药物。在完成治疗后，退伍军人将被转介给丁丙诺啡 目前正在进行临床护理，并将进入第三阶段的研究，即随访。在这一阶段，他们将 分别于治疗结束后1个月和3个月出现。