Cognitive Behavioral Therapy (CBT-I) Augmentation of Topiramate in promoting abstinence in alcohol use disorder (AUD).

认知行为疗法 (CBT-I) 增强托吡酯促进酒精使用障碍 (AUD) 戒酒的作用。

• 批准号: 10578700
• 负责人: Subhajit Chakravorty
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10578700
• 关键词: Abstinence; Aftercare; Alcohol consumption; Alcohols; Anticonvulsants; Anxiety; Back; Beck depression inventory; Behavior Therapy; Behavioral; Caring; Clinical; Cognitive Therapy; Combined Modality Therapy; Communities; Comorbid Insomnia; Development; Disulfiram; Education; Epilepsy; Equipment and supply inventories; Exhibits; FDA approved; General Population; Guidelines; Heavy Drinking; Hygiene; Impairment; Individual; Intervention; Interview; Measures; Meta-Analysis; Migraine; Multicenter Trials; Naltrexone; Outcome; Outcome Measure; Pathologic; Patients; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Prevalence; Protocols documentation; Quality of life; Randomized; Recommendation; Recovery; Relapse; Reporting; Risk; Sampling; Severities; Sleep; Sleep disturbances; Sleeplessness; Stimulus; Suicide; Testing; Time; Titrations; Trazodone; Veterans; Visit; acamprosate; actigraphy; affective disturbance; alcohol abstinence; alcohol abuse therapy; alcohol comorbidity; alcohol craving; alcohol use disorder; arm; comorbidity; craving; daily functioning; design; diaries; dosage; drinking; drinking behavior; follow-up; gabapentin; high risk; hypnotic; improved; improvement on sleep; indexing; innovation; off-label drug; personalized intervention; post intervention; prevent; primary outcome; recidivism; relapse risk; side effect; sleep health; sobriety; suicidal behavior; suicidal risk; timeline; topiramate; trait; treatment effect; treatment guidelines; validation studies

Abstract Alcohol Use Disorder (AUD) and insomnia are both more prevalent among Veterans than in the general population. While insomnia is 3-9 times more prevalent in AUD than in the general population, patients with comorbid AUD and insomnia suffer from higher severity of AUD with increased alcohol craving, reduced quality of life, impaired interpersonal functioning, higher risks for suicidal behavior and relapse during early abstinence. There are limited options to treat drinking behavior and insomnia due to side effect profile (disulfiram) or only modest impact on drinking outcomes (naltrexone and acamprosate). Topiramate (TOP), an FDA-approved medication for seizures and migraines, showed moderate effect sizes in achieving abstinence and decreasing craving, when compared to placebo, in a recent meta-analysis. However, TOP therapy did not provide clinical improvement in objective sleep or subjective insomnia. Furthermore, hypnotic medication treatments with trazodone, gabapentin, and ramelteon have shown variable impact for sleep disturbance and abstinence. By contrast, all four studies evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) have shown a large magnitude of effect for treating insomnia but with minimal to no effect on abstinence. Thus, combining TOP and CBT-I will strengthen their recovery and improve their overall functioning. This combination treatment will be the first personalized intervention in treating Veterans with AUD and comorbid insomnia. A sample of treatment-seeking Veterans with AUD (N=174) will be initially treated with TOP 200 mg a day for six weeks, and then randomized to receive either CBT-I (N=87) or Sleep Hygiene Education (SHE, a behavioral placebo intervention) (N=87) weekly for the next eight weeks. We will conduct CBT-I following our standard protocol using 30-minute sessions to deliver its components (Sleep Restriction, Stimulus Control, Sleep Hygiene and Cognitive Therapy). A post-intervention visit will be conducted eight weeks after the intervention phase. The primary outcome measure will be the Percent Days Abstinent (as computed from the Time Line Follow Back interview) and the insomnia severity (as assessed using the Insomnia Severity Index). Also, we will track other aspects of alcohol use, sleep and daily functioning using TLFB, PACS, sleep diaries, BDI, and the STAI to test whether successful treatment of drinking and insomnia will be associated with better clinical outcomes in AUD. It is hypothesized that in Veterans with AUD, the combination of TOP+CBT-I, as compared to TOP+SHE group, will lead to 1) a more significant percentage of days abstinent from alcohol, and 2) superior sleep-related outcomes along with pre-post treatment effect sizes comparable to the meta-analytic norms. If these hypotheses are supported, the findings will need to be validated in a larger multi-center trial. If validated, the findings would support: 1) including insomnia treatment as a standard component of the initial protocol for treating AUD comorbid with insomnia, and 2) using TOP+CBT-I combination treatment to manage this subpopulation of AUD patients.

抽象的 酒精使用障碍 (AUD) 和失眠在退伍军人中比一般人更普遍 人口。虽然 AUD 患者的失眠发生率是普通人群的 3-9 倍，但患有以下疾病的患者 患有 AUD 和失眠的共病 AUD 的严重程度更高，并且对酒精的渴望增加，质量下降 生活质量下降、人际功能受损、自杀行为和早期复发的风险较高 节制。由于副作用，治疗饮酒行为和失眠的选择有限 （双硫仑）或对饮酒结果影响不大（纳曲酮和阿坎酸）。托吡酯 (TOP) FDA 批准的治疗癫痫和偏头痛的药物在实现戒断方面显示出中等的效果 在最近的一项荟萃​​分析中，与安慰剂相比，食欲下降。然而，TOP疗法并没有 提供客观睡眠或主观失眠的临床改善。另外，安眠药 曲唑酮、加巴喷丁和雷美替尼治疗对睡眠障碍和睡眠障碍有不同的影响 节制。相比之下，所有四项评估失眠认知行为疗法（CBT-I）的研究都 对治疗失眠有很大的效果，但对戒欲的影响很小甚至没有。因此， TOP 和 CBT-I 的结合将加强他们的康复并改善他们的整体功能。这 联合治疗将是治疗患有 AUD 和合并症的退伍军人的第一个个性化干预措施 失眠。 寻求治疗的 AUD 退伍军人样本 (N=174) 最初将接受 TOP 200 mg a 治疗 为期六周的一天，然后随机接受 CBT-I (N=87) 或睡眠卫生教育 (SHE，a 在接下来的八周内每周进行行为安慰剂干预（N=87）。我们将按照我们的要求进行 CBT-I 标准协议使用 30 分钟的会话来提供其组件（睡眠限制、刺激控制、 睡眠卫生和认知治疗）。干预后访视将在干预后八周进行 干预阶段。主要结果指标是禁欲天数百分比（根据 时间线跟踪访谈）和失眠严重程度（使用失眠严重程度指数进行评估）。 此外，我们将使用 TLFB、PACS、睡眠日记、 BDI 和 STAI 旨在测试成功治疗饮酒和失眠是否会带来更好的效果 临床结果（澳元）。据推测，在患有 AUD 的退伍军人中，TOP+CBT-I 的组合，如 与 TOP+SHE 组相比，将导致 1) 戒酒天数比例更高，并且 2) 与荟萃分析相当的优异的睡眠相关结果以及治疗前后的效果大小 规范。如果这些假设得到支持，研究结果将需要在更大规模的多中心试验中得到验证。如果 经过验证，研究结果将支持：1）将失眠治疗作为初始治疗的标准组成部分 治疗 AUD 合并失眠的方案，以及 2) 使用 TOP+CBT-I 联合治疗来管理 AUD 患者的这个亚群。