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 在退伍军人中，酒精使用障碍（AUD）和失眠都比一般 人口。虽然失眠在AUD中的普遍比一般人群高3-9倍，但 合并的AUD和失眠症患者的严重程度更高，渴望降低，质量降低，质量降低 生命，人际职能受损，自杀行为的较高风险和早期复发 节制。由于副作用轮廓，治疗饮酒行为和失眠的选择有限 （二硫仑）或仅对饮酒结果（纳曲酮和丙型酯）的影响。托吡酯（顶部），an FDA批准的用于癫痫发作和偏头痛的药物在实现禁欲方面显示出适中的效果大小 在最近的荟萃分析中，与安慰剂相比，渴望减少了。但是，最高疗法没有 提供客观睡眠或主观失眠的临床改善。此外，催眠药物 用曲唑酮，加巴喷丁和拉梅尔特恩治疗对睡眠障碍和 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 对治疗失眠的影响很大，但对禁欲没有影响。因此， 结合顶部和CBT-I将加强其恢复并提高其整体功能。这 联合处理将是第一个个性化干预措施，以使用AUD和合并症治疗退伍军人 失眠。 最初将用AUD（n = 174）的寻求治疗的退伍军人样本使用前200 mg A进行处理 一天持续六个星期，然后随机接受CBT-I（n = 87）或睡眠卫生教育（她，一个 行为安慰剂干预）（n = 87）每周在接下来的八周内。我们将执行CBT-I之后 使用30分钟的会话进行标准协议来提供其组件（睡眠限制，刺激控制， 睡眠卫生和认知疗法）。干预后访问将在 干预阶段。主要结局指标将是节制的百分比（按照从 时间线跟随访谈）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，睡眠日记跟踪酒精使用，睡眠和日常功能的其他方面 BDI和STAI测试成功治疗饮酒和失眠是否会更好 AUD的临床结果。假设在具有AUD的退伍军人中，TOP+CBT-I的组合为 与Top+She组相比，将导致1）避免酒精的天数，并且 2）与睡眠相关的优势以及与荟萃分析相当的前孔治疗效果大小 规范。如果支持这些假设，则需要在更大的多中心试验中验证这些发现。如果 经过验证，调查结果将支持：1）包括失眠治疗作为初始的标准组成部分 用于治疗失眠的AUD合并的协议，以及2）使用TOP+CBT-I组合处理来管理 AUD患者的这种亚群。