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减少药物使用作为兴奋剂使用障碍个体的另一种有效结局:来自 13 个多中心随机临床试验的结果。

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

机构信息

Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Iranian National Center for Addiction Studies (INCAS), Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Addiction. 2024 May;119(5):833-843. doi: 10.1111/add.16409. Epub 2024 Jan 10.

Abstract

BACKGROUND AND AIMS

Total abstinence has historically been the goal of treatment for substance use disorders; however, there is a growing recognition of the health benefits associated with reduced use as a harm reduction measure in stimulant use disorders treatment. We aimed to assess the validity of reduced stimulant use as an outcome measure in randomized controlled trials (RCTs) of pharmacological interventions for stimulant use disorder.

DESIGN

We conducted a secondary analysis of a pooled dataset of 13 RCTs.

SETTING AND PARTICIPANTS

Participants were individuals seeking treatment for cocaine or methamphetamine use disorders (N = 2062) in a wide range of treatment facilities in the United States.

MEASUREMENTS

We validated reduced stimulant use against a set of clinical indicators drawn from harmonized measurements, including severity of problems caused by drug use, comorbid depression, global severity of substance use and improvement, severity of drug-seeking behavior, craving and high-risk behaviors, all assessed at the end of the trial, as well as follow-up urine toxicology. A series of mixed effect regression models was conducted to validate reduction in frequency of use against no reduction in use and abstinence.

FINDINGS

More participants reduced frequency of primary drug use than achieved abstinence (18.0% vs. 14.2%, respectively). Reduced use was significantly associated with decreases in craving for the primary drug [60.1%, 95% confidence interval (CI) = 54.3%-64.7%], drug seeking behaviors (41.0%, 95% CI = 36.6%-45.7%), depression severity (39.9%, 95% CI = 30.9%-48.3%), as well as multiple measures of global improvement in psychosocial functioning and severity of drug-related problems, albeit less strongly so than abstinence. Moreover, reduced use was associated with sustained clinical benefit at follow-up, as confirmed by negative urine tests (adjusted odds ratio compared with those with no reduction in use: 0.50, 95% CI = 0.35-0.71).

CONCLUSION

Reduced frequency of stimulant use appears to be associated with meaningful improvement in various clinical indicators of recovery. Assessment of reduced use, in addition to abstinence, could broaden the scope of outcomes measured in randomized controlled trials of stimulant use disorders and facilitate the development of more diverse treatment approaches.

摘要

背景与目的

在物质使用障碍的治疗中,完全戒除一直是治疗的目标;然而,越来越多的人认识到,减少使用量作为减少兴奋剂使用障碍治疗中伤害的一种措施与健康益处相关。我们旨在评估减少兴奋剂使用作为随机对照试验(RCT)中药理学干预治疗兴奋剂使用障碍的结果测量的有效性。

方法

我们对 13 项 RCT 的汇总数据集进行了二次分析。

设置和参与者

参与者是在美国各种治疗设施中寻求可卡因或甲基苯丙胺使用障碍治疗的个人(N=2062)。

测量

我们通过一套来自协调测量的临床指标来验证减少兴奋剂的使用,包括药物使用引起的问题的严重程度、共病抑郁、物质使用和改善的总体严重程度、觅药行为、渴求以及高危行为的严重程度,所有这些都是在试验结束时以及随访尿液毒理学检测时评估的。我们进行了一系列混合效应回归模型,以验证减少使用频率与不减少使用和戒除之间的关系。

结果

更多的参与者减少了主要药物的使用频率,而不是达到了戒除(分别为 18.0%和 14.2%)。减少使用与对主要药物的渴求降低显著相关[60.1%,95%置信区间(CI)=54.3%-64.7%]、觅药行为(41.0%,95% CI=36.6%-45.7%)、抑郁严重程度(39.9%,95% CI=30.9%-48.3%),以及心理社会功能和药物相关问题严重程度的多个综合改善指标,尽管不如戒除那样强烈。此外,减少使用与随访时的持续临床获益相关,这一点得到了阴性尿液检测的证实(与无减少使用相比,调整后的优势比:0.50,95% CI=0.35-0.71)。

结论

减少兴奋剂的使用频率似乎与恢复的各种临床指标的显著改善相关。除了戒除之外,评估减少使用量可以扩大兴奋剂使用障碍随机对照试验中测量的结果范围,并促进更广泛的治疗方法的发展。

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