亚慢性大麻二酚口腔黏膜喷雾剂对参与大麻使用障碍治疗临床试验个体生物标志物的影响
Effects of sub-chronic nabiximols on biological markers of individuals undergoing a clinical trial for the treatment of cannabis use disorder.
作者信息
Wang Ruoyu, Trigo Jose M, Le Foll Bernard
机构信息
Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health Toronto, Ontario, Canada.
Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto Toronto, Ontario, Canada.
出版信息
Am J Transl Res. 2023 Aug 15;15(8):5228-5238. eCollection 2023.
OBJECTIVE
Nabiximols is used for treating various symptoms associated with multiple sclerosis (MS). Nabiximols is also being investigated as a potential treatment medication for individuals with cannabis use disorder (CUD). A variety of investigations have shown that, at low doses, nabiximols is overall well tolerated for MS treatment. However, due to tolerance, the management of CUD would likely require much higher doses of nabiximols to be effective. The effects of high doses of nabiximols on clinical laboratory tests remain unclear. Therefore, we investigated the sub-chronic effects of high doses of nabiximols on liver function, renal function, and other routine blood tests in this prospective study.
METHODS
We performed a secondary analysis of various blood markers results collected during a double-blind, placebo-controlled randomized clinical trial (Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence, NCT01747850, https://clinicaltrials.gov/ct2/show/record/NCT01747850). This trial tested the impact of the 12-week administration of nabiximols with a maximum daily dose of up to 113.4 mg THC/105 mg CBD.
RESULTS
The measurements of the various biomarkers were in the normal range during the 12-week time frame. The results indicate an overall good tolerability of high-dose nabiximols on the blood markers measured.
CONCLUSION
Our preliminary results suggest that high doses of nabiximols might be well tolerated by individuals with CUD.
目的
纳比西林用于治疗与多发性硬化症（MS）相关的各种症状。纳比西林也正在被研究作为一种治疗大麻使用障碍（CUD）个体的潜在治疗药物。各种研究表明，在低剂量时，纳比西林对MS治疗总体耐受性良好。然而，由于耐受性，治疗CUD可能需要更高剂量的纳比西林才能有效。高剂量纳比西林对临床实验室检查的影响仍不清楚。因此，在这项前瞻性研究中，我们调查了高剂量纳比西林对肝功能、肾功能和其他常规血液检查的亚慢性影响。
方法
我们对在一项双盲、安慰剂对照随机临床试验（大麻依赖中的纳比西林和行为复发预防策略，NCT01747850，https://clinicaltrials.gov/ct2/show/record/NCT01747850）期间收集的各种血液标志物结果进行了二次分析。该试验测试了每日最大剂量高达113.4 mg THC/105 mg CBD的纳比西林给药12周的影响。
结果
在12周的时间范围内，各种生物标志物的测量值均在正常范围内。结果表明高剂量纳比西林对所测血液标志物总体耐受性良好。
结论
我们的初步结果表明，高剂量纳比西林可能被CUD个体良好耐受。
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