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Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence.
JAMA Internal Medicine ( IF 39.0 ) Pub Date : 2020-01-01 , DOI: 10.1001/jamainternmed.2019.5664
Frances R Levin 1 , John J Mariani 1
Affiliation  

To the Editor We read with interest the recently published randomized clinical trial by Lintzeris and colleagues1 reporting that use of nabiximols was superior to placebo in reducing days of cannabis use. To date, there are no US Food and Drug Administration–approved medications for the treatment of cannabis use disorder, and novel interventions are sorely needed. The authors state that the study findings are clinically significant because there were fewer days of use in the nabiximols arm compared with the placebo arm (ie, a mean difference of 18.6 days over the study period). However, the substantiation of this assertion is not provided. Based on the data presented, the nabiximols group averaged 4.4 d/wk and the placebo group averaged 2.9 d/wk during the trial. As noted by the authors, the 2 groups did not differ at the end of study in measured health or psychosocial outcomes. This finding illustrates a dilemma that the field finds itself in with regard to nonabstinence outcomes: what degree of cannabis use reduction is clinically meaningful if there is no measured change in health or quality of life? As noted by Lee and colleagues2 there have been numerous primary outcomes employed in marijuana pharmacologic treatment trials, but short of abstinence, there is not a consensus on what that clinically meaningful outcome would be.



中文翻译:

纳比西莫斯治疗大麻依赖性的临床意义和结果。

致编辑我们感兴趣地阅读了Lintzeris及其同事最近发表的随机临床试验1报告称,在减少使用大麻的天数方面,使用萘比莫斯优于安慰剂。迄今为止,还没有美国食品和药物管理局批准的用于治疗大麻使用障碍的药物,因此迫切需要新的干预措施。作者指出,该研究结果具有临床意义,因为与安慰剂组相比,萘比莫斯组的使用天数更少(即,研究期间的平均差为18.6天)。但是,没有提供该断言的证据。根据提供的数据,在试验期间,纳比昔莫尔组平均为4.4 d / wk,安慰剂组为平均2.9 d / wk。正如作者所指出的,在研究结束时,两组的健康或心理社会结果没有差异。这一发现说明了该领域在禁欲结果方面的困境:如果没有健康或生活质量的可衡量变化,减少大麻使用的程度在临床上是有意义的?正如李和同事所指出的2在大麻药物治疗试验中已经采用了许多主要结果,但由于缺乏戒断,对于具有临床意义的结果仍未达成共识。

更新日期:2020-01-06
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