Varenicline as a treatment for cannabis use disorder: A placebo-controlled pilot trial.
Varenicline as a treatment for cannabis use disorder: A placebo-controlled pilot trial.
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DOI：
10.1016/j.drugalcdep.2021.109111
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发表时间：
2021-12-01
影响因子：
4.2
通讯作者：
Tomko R
中科院分区：
文献类型：
--
作者：
McRae-Clark AL;Gray KM;Baker NL;Sherman BJ;Squeglia L;Sahlem GL;Wagner A;Tomko R
大麻使用障碍（CUD）的有效药物治疗尚未确定。本研究通过概念验证临床试验初步评价了伐尼克兰治疗冠心病的安全性和有效性。在这项为期6周的随机、安慰剂对照先导试验中，参与者接受了伐尼克兰（n=35）或安慰剂（n=37），并加入了简短的动机增强治疗干预。结果包括大麻戒断、大麻戒断、尿液大麻素水平、大麻使用天数百分比和每天吸食大麻的次数。与基线相比，两个治疗组都注意到自我报告的大麻戒断，使用天数百分比和治疗期间每天使用次数显着减少。虽然这项试点试验没有能力检测组间的统计学差异，但随机分配到伐尼克兰的参与者在最后的研究访问中证明了更高的自我报告戒断率[第6周意向治疗（ITT）：伐尼克兰：17.1% vs安慰剂：5.4%；Rr =3.2 (95% ci: 0.7,14.7)]。与基线相比，治疗结束时，伐尼克兰组尿肌酐校正后的大麻素水平在数值上较低，而安慰剂组较高[基线变化：伐尼克兰- 1.7 ng/mg (95% CI: - 4.1,0.8) vs安慰剂：1.9 ng/mg (95% CI: - 0.4,4.3)；Δ=3.5 (95% ci: 0.1,6.9)]。与研究治疗相关的不良事件未显示新的安全信号。研究结果支持将伐尼克兰作为CUD的候选药物治疗进行临床试验的可行性，并表明基于本研究中产生的效应大小和可变性，有必要进行全面的疗效试验。
An efficacious pharmacotherapy for cannabis use disorder (CUD) has yet to be established. This study preliminarily evaluated the safety and efficacy of varenicline for CUD in a proof-of-concept clinical trial. Participants in this 6-week randomized, placebo-controlled pilot trial received either varenicline (n=35) or placebo (n=37), added to a brief motivational enhancement therapy intervention. Outcomes included cannabis withdrawal, cannabis abstinence, urine cannabinoid levels, percent cannabis use days, and cannabis sessions per day. Both treatment groups noted significant decreases in self-reported cannabis withdrawal, percentage of days used, and use sessions per day during treatment compared to baseline. While this pilot trial was not powered to detect statistically significant between-group differences, participants randomized to varenicline evidenced numerically greater rates of self-reported abstinence at the final study visit [Week 6 intent-to-treat (ITT): Varenicline: 17.1% vs. Placebo: 5.4%; RR=3.2 (95% CI: 0.7,14.7)]. End-of-treatment urine creatinine corrected cannabinoid levels were numerically lower in the varenicline group and higher in the placebo group compared to baseline [Change from baseline: Varenicline −1.7 ng/mg (95% CI: −4.1,0.8) vs. Placebo: 1.9 ng/mg (95% CI: −0.4,4.3); Δ=3.5 (95% CI: 0.1,6.9)]. Adverse events related to study treatment did not reveal new safety signals. Findings support the feasibility of conducting clinical trials of varenicline as a candidate pharmacotherapy for CUD, and indicate that a full-scale efficacy trial, powered based on effect sizes and variability yielded in this study, is warranted.
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作者：
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