Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America; Ralph H. Johnson VA Medical Center, Charleston, SC, United States of America.
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.
Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109111. doi: 10.1016/j.drugalcdep.2021.109111. Epub 2021 Sep 28.
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.
目前尚未确定有效的大麻使用障碍（CUD）药物治疗方法。本研究初步评估了伐伦克林治疗 CUD 的安全性和疗效，这是一项概念验证性临床试验。
在这项为期 6 周的随机、安慰剂对照的初步试验中，参与者接受了伐伦克林（n=35）或安慰剂（n=37）治疗，同时接受了简短的动机增强治疗干预。结果包括大麻戒断、大麻禁欲、尿液中大麻素水平、大麻使用天数百分比和每天大麻使用次数。
两组治疗组在治疗期间与基线相比，自我报告的大麻戒断、使用天数百分比和使用次数均显著减少。虽然本试验未达到检测组间统计学差异的效力，但在最后一次研究访视时，随机接受伐伦克林治疗的参与者报告的禁欲率更高[第 6 周意向治疗（ITT）：伐伦克林：17.1%比安慰剂：5.4%；RR=3.2（95%CI：0.7，14.7)]。与基线相比，伐伦克林组治疗结束时尿液肌酐校正大麻素水平数值较低，安慰剂组较高[与基线相比的变化：伐伦克林-1.7ng/mg（95%CI：-4.1，0.8）比安慰剂：1.9ng/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揭示新的安全信号。
研究结果支持开展伐伦克林治疗 CUD 的临床试验，表明需要开展一项基于本研究中得出的效应大小和变异性的大规模疗效试验。
