Short-term Outcome of Stimulant Use Disorder Treatment Trials

兴奋剂使用障碍治疗试验的短期结果

• 批准号: 10671072
• 负责人: RAMIN MOJTABAI
• 金额: $ 40.94万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10671072
• 关键词: Abstinence; Age; American; Baclofen; Bupropion; Characteristics; Chronic; Clinical; Clinical Treatment; Clinical Trials Network; Cocaine; Cocaine use disorder; Combination Medication; Combined Modality Therapy; Complex; Data; Dependence; Distress; Dropout; Drug usage; Effectiveness; Epidemic; Equilibrium; Ethnic Origin; Evaluation; FDA approved; Fatality rate; Frequencies; Future; Health; Heterogeneity; Individual; Measures; Mediating; Mediator; Methamphetamine; Methamphetamine use disorder; Modafinil; Naltrexone; National Institute of Drug Abuse; Nicotine Use Disorder; Ondansetron; Opioid; Outcome; Overdose; Participant; Patient Participation; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Probability; Property; Publications; Race; Randomized, Controlled Trials; Recurrence; Relapse; Research; Reserpine; Role; Sample Size; Sampling; Selegiline; Severities; Signal Transduction; Stimulant; Structural Models; Subgroup; Substance Use Disorder; Substance Withdrawal Syndrome; Symptoms; Techniques; Treatment outcome; Variant; Withdrawal; Withdrawal Symptom; alcohol abuse therapy; alcohol craving; alcohol use disorder; analytical method; behavioral phenotyping; cabergoline; candidate identification; clinically relevant; comorbidity; craving; data harmonization; depressive symptoms; drug craving; drug relapse; drug seeking behavior; experience; follow-up; morphogens; nicotine craving; nicotine treatment; novel; patient subsets; prolonged abstinence; psychological distress; response; sex; social; standard of care; stimulant misuse; stimulant use; stimulant use disorder; stimulant user; substance use; tiagabine; topiramate; treatment effect; treatment trial

Project Summary Stimulant use disorders, including cocaine and methamphetamine use disorders, impact the lives of millions of Americans and are associated with significant health and social consequences. There are currently no FDA- approved medications for treatment of stimulant use disorders. Most of the randomized controlled trials (RCTs) to find effective medications have been of short duration, typically lasting 8-12 weeks, and had small sample sizes. Attaining sustained abstinence from stimulants may require longer treatment and detecting these effects may require larger samples. However, available trials can provide information on short-term outcomes of treatment that are achieved earlier and less stringent than abstinence and, thus, help identify candidate medications for future long-term and larger trials. Drug craving is probably the most promising of such short- term outcomes. Stimulant use disorders are characterized by periods of heavy use followed by short periods of abstinence with withdrawal symptoms. These symptoms last a few days and are followed by increasing drug craving which often leads to relapse. Drug craving is a central phenomenon in these recurring cycles of drug use. Nevertheless, little research has specifically focused on craving as an outcome of stimulant use disorder or on reduction of craving as a mediator of abstinence or reduction in drug use. In the proposed project, we plan to examine craving as an outcome of stimulant use disorder as well as a mediator for other outcomes. More specifically, in Aim 1, we will compare the effect of 9 medications (in 11 RCTs) on stimulant drug craving. In Aim 2, we will assess the association of change in craving during trial with change in other outcomes and the potential mediating role of craving in the effect of treatments on these outcomes. In Aim 3 we will explore the variations in the effects of medications and in the association of craving with other outcomes in subgroups of patients. We propose to use individual participant data from 1,845 patients in 11 RCTs conducted in the context of NIDA’s Clinical Trials Network (CTN) and related trials to accomplish these study Aims. The project has the potential to significantly contribute to a better understanding of the role of craving in continued stimulant use disorder and the potential effect of medications on stimulant use disorders as mediated by their anti-craving qualities. Medications with anti-craving properties are currently used in treatment of nicotine and alcohol use disorders and have shown promising results in treatment of stimulant use disorders. The project also represents an efficient use of NIDA’s RCT data to answer new questions that were not addressed in the original studies. The findings would help identify candidate medications for future adequately powered trials based on the short-term anti-craving effects of candidate medications and contribute significantly to the ongoing efforts to find effective medication treatments for stimulant use disorders.

项目摘要 刺激性使用障碍，可卡因和甲基苯丙胺的使用障碍，影响了数百万的生命 美国人，与重大的健康和社会解决方案有关。 批准治疗刺激使用障碍的药物。 寻找有效的药物的持续时间很短，通常持续8-12周，样品很少 大小。 可能需要较大的样本。 早期疼痛和不太严格的治疗，因此有助于识别候选人 未来的长期和较大试验的药物。 术语结果。 戒断症状的禁欲。 渴望通常导致毒品渴望。 使用。 或减少渴望作为毒品使用的渴望。 计划将渴望作为刺激性美国疾病的结果以及结果的调解人进行研究。 更具体地说，在AIM 1中，我们将比较9种药物（分别为11个RCT）对兴奋剂渴望的影响。 在AIM 2中，我们将评估试验期间渴望变化的关联与结果和结果的变化以及 渴望在治疗对结果的影响中的潜在中介作用。 药物的影响以及渴望与亚组结果的影响的变化 我们建议使用来自1,845名患者的个人参与者数据 NIDA临床网络（CTN）和相关试验的背景是完成这些项目的 有潜力有助于更好地理解渴望在持续中的作用 刺激性使用障碍以及药物对刺激使用障碍的潜在影响，其介导 目前，抗腐蚀性的抗药性。 酒精疾病并显示出令人鼓舞的兴奋性疾病的结果 还代表了NIDA的RCT数据的效率，以回答未解决的新问题 原始研究将有助于识别候选药物的药物 基于念珠化药物的短期抗纪念作用 正在进行的努力寻找有效的药物治疗治疗刺激性疾病。