Masoumeh Amin-Esmaeili, Mehdi Farokhnia, Ryoko Susukida, Lorenzo Leggio, Renee M. Johnson, Rosa M. Crum, Ramin Mojtabai
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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.</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>We conducted a secondary analysis of a pooled dataset of 13 RCTs.</p>\n </section>\n \n <section>\n \n <h3> Setting and participants</h3>\n \n <p>Participants were individuals seeking treatment for cocaine or methamphetamine use disorders (<i>N</i> = 2062) in a wide range of treatment facilities in the United States.</p>\n </section>\n \n <section>\n \n <h3> Measurements</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Findings</h3>\n \n <p>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).</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Reduced frequency of stimulant use appears to be associated with meaningful improvement in various clinical indicators of recovery. 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引用次数: 0
摘要
背景和目的：完全禁欲历来是药物使用障碍的治疗目标；然而，在刺激剂使用障碍治疗中，人们越来越认识到减少使用刺激剂作为一种减低伤害的措施所带来的健康益处。我们旨在评估将减少使用兴奋剂作为兴奋剂使用障碍药物干预随机对照试验（RCT）结果衡量标准的有效性：我们对 13 项随机对照试验的汇总数据集进行了二次分析：参与者为在美国各种治疗机构寻求可卡因或甲基苯丙胺使用障碍治疗的人（N = 2062）：我们根据一套统一测量方法得出的临床指标验证了兴奋剂使用量的减少，这些指标包括药物使用导致的问题的严重程度、合并抑郁症、药物使用的整体严重程度和改善情况、寻求毒品行为的严重程度、渴求和高危行为，所有指标均在试验结束时进行评估，以及后续尿液毒理学检查。我们采用了一系列混合效应回归模型来验证吸毒频率的减少与吸毒和戒毒的不减少之间的差异：结果：减少主要药物使用频率的参与者多于戒断者（分别为 18.0% 和 14.2%）。减少用药次数与减少对主要毒品的渴求[60.1%，95% 置信区间 (CI) = 54.3%-64.7%]、减少寻求毒品的行为（41.0%，95% CI = 36.6%-45.7%）、减少抑郁的严重程度（39.9%，95% CI = 30.9%-48.3%），以及减少社会心理功能和毒品相关问题严重程度的多种全面改善措施都有明显的关系，尽管这种关系不如禁欲强烈。此外，减少用药与随访时的持续临床获益相关，尿检呈阴性也证实了这一点（与未减少用药者相比，调整后的几率比为 0.50，95% CI）：结论：结论：减少兴奋剂的使用频率似乎与各种临床康复指标的显著改善有关。除戒断外，对减少使用的评估可拓宽兴奋剂使用障碍随机对照试验的测量结果范围，并有助于开发更多样化的治疗方法。
Reduced drug use as an alternative valid outcome in individuals with stimulant use disorders: Findings from 13 multisite randomized clinical trials
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.
期刊介绍：
Addiction publishes peer-reviewed research reports on pharmacological and behavioural addictions, bringing together research conducted within many different disciplines.
Its goal is to serve international and interdisciplinary scientific and clinical communication, to strengthen links between science and policy, and to stimulate and enhance the quality of debate. We seek submissions that are not only technically competent but are also original and contain information or ideas of fresh interest to our international readership. We seek to serve low- and middle-income (LAMI) countries as well as more economically developed countries.
Addiction’s scope spans human experimental, epidemiological, social science, historical, clinical and policy research relating to addiction, primarily but not exclusively in the areas of psychoactive substance use and/or gambling. In addition to original research, the journal features editorials, commentaries, reviews, letters, and book reviews.
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