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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要兴奋剂使用障碍，包括可卡因和甲基苯丙胺使用障碍，影响着数百万人的生活美国人，目前没有 FDA- 与重大健康和社会后果相关。大多数随机对照试验（RCT）均已批准用于治疗兴奋剂使用障碍的药物。寻找有效药物的持续时间较短，通常持续 8-12 周，且样本量较小持续戒除兴奋剂可能需要更长时间的治疗并检测这些影响。可能需要更大的样本。然而，现有的试验可以提供有关短期结果的信息。与禁欲相比，治疗更早实现且不那么严格，因此有助于确定候选治疗方案用于未来长期和更大规模试验的药物可能是此类短期试验中最有希望的。兴奋剂使用障碍的特点是一段时期内大量使用，随后短期内使用。戒断症状伴随戒断症状，这些症状会持续几天，然后药物会逐渐增加。药物渴求常常导致复发，这是这些药物循环中的一个核心现象。然而，很少有研究专门关注兴奋剂使用障碍导致的渴望。或减少渴望作为戒断或减少药物使用的中介。计划将渴望作为兴奋剂使用障碍的结果以及其他结果的中介因素进行检查。更具体地说，在目标 1 中，我们将比较 9 种药物（在 11 项随机对照试验中）对兴奋剂药物渴望的影响。在目标 2 中，我们将评估试验期间渴望变化与其他结果变化之间的关联，在目标 3 中，我们将探讨渴望在治疗效果中的潜在中介作用。亚组中药物作用的差异以及渴望与其他结果之间的关联我们建议使用 11 项随机对照试验中 1,845 名患者的个体参与者数据。 NIDA 临床试验网络 (CTN) 和相关试验的背景，以实现这些研究目标。有潜力为更好地理解渴望在持续的过程中的作用做出重大贡献兴奋剂使用障碍以及药物对兴奋剂使用障碍的潜在影响（由其介导）具有抗渴求特性的药物目前用于治疗尼古丁和烟瘾。该项目在治疗酒精使用障碍方面显示出可喜的成果。也代表了对 NIDA 的 RCT 数据的有效利用来回答 NIDA 中未解决的新问题原始研究结果将有助于确定未来足够有力的试验的候选药物。基于候选药物的短期抗渴求作用，并对持续努力寻找治疗兴奋剂使用障碍的有效药物治疗方法。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Reduced drug use as an alternative valid outcome in individuals with stimulant use disorders: Findings from 13 multisite randomized clinical trials.

减少药物使用作为兴奋剂使用障碍个体的替代有效结果：13 项多中心随机临床试验的结果。

DOI：
发表时间：
2024-05
期刊：
影响因子：
0
作者：
Amin;Farokhnia, Mehdi;Susukida, Ryoko;Leggio, Lorenzo;Johnson, Renee M;Crum, Rosa M;Mojtabai, Ramin
通讯作者：
Mojtabai, Ramin