What defines a clinically meaningful outcome in the treatment of substance use disorders: reductions in direct consequences of drug use or improvement in overall functioning?
What defines a clinically meaningful outcome in the treatment of substance use disorders: reductions in direct consequences of drug use or improvement in overall functioning?
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DOI：
10.1111/add.14289
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发表时间：
2019-01-01
期刊：
影响因子：
6
通讯作者：
Weiss, Roger D.
中科院分区：
文献类型：
--
作者：
Kiluk, Brian D.;Fitzmaurice, Garrett M.;Weiss, Roger D.
背景 持续戒酒是目前大多数物质使用障碍 (SUD) 药物治疗试验唯一可接受的终点（酒精除外）。尽管最近做出了努力，但将非戒断替代方案确定为具有临床意义的药物使用试验终点一直难以实现。论证和分析 目前在 SUD 试验中建立具有临床意义的结果的标准是证明药物使用的减少与长期功能的改善相关，但数据表明药物使用与各种心理社会问题领域之间的关联相对较弱。这可能是因为最常用于衡量个人功能的评估并未具体说明功能的各个方面是否是吸毒的直接后果。尽管旨在评估吸毒直接后果的措施很少被纳入药物治疗功效试验中，但酒精使用障碍试验中非戒酒终点的接受部分是因为与酒精相关后果的减少有关。结论 物质使用障碍领域应包括对药物使用的负面心理社会和健康后果的测量，而不是对整体功能的测量，以努力建立有意义的非戒断终点。
Background Sustained abstinence is currently the only accepted end-point for pharmacotherapy trials for most substance use disorders (SUD), with the exception of alcohol. Despite recent efforts, the identification of a non-abstinence alternative as a clinically meaningful end-point for drug use trials has been elusive. Argument and analysis The current standard for establishing a clinically meaningful outcome in SUD trials is to demonstrate that a reduction in drug use is associated with improvement in long-term functioning, but data indicate relatively weak associations between drug use and various psychosocial problem domains. This may be because assessments used most commonly to measure an individual's functioning do not specify whether aspects of functioning are a direct consequence of drug use. The acceptance of a non-abstinence-based end-point for alcohol use disorder trials was supported in part through associations with reductions in alcohol-related consequences, although measures designed to assess the direct consequences of drug use are rarely included in drug treatment efficacy trials. Conclusions The field of substance use disorders should include measures of negative psychosocial and health consequences of drug use, as opposed to overall functioning, in the effort to establish meaningful non-abstinence-based end-points.