辅助氯胺酮联合基于预防复发的心理治疗用于酒精使用障碍的治疗
Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder.
作者信息
Grabski Meryem, McAndrew Amy, Lawn Will, Marsh Beth, Raymen Laura, Stevens Tobias, Hardy Lorna, Warren Fiona, Bloomfield Michael, Borissova Anya, Maschauer Emily, Broomby Rupert, Price Robert, Coathup Rachel, Gilhooly David, Palmer Edward, Gordon-Williams Richard, Hill Robert, Harris Jen, Mollaahmetoglu O Merve, Curran H Valerie, Brandner Brigitta, Lingford-Hughes Anne, Morgan Celia J A
机构信息
Psychopharmacology and Addiction Research Centre (Grabski, McAndrew, Marsh, Raymen, Stevens, Hardy, Maschauer, Palmer, Mollaahmetoglu, Morgan) and College of Medicine and Health (Warren), University of Exeter, Exeter, U.K.; Clinical Psychopharmacology Unit (Grabski, Lawn, Marsh, Bloomfield, Borissova, Curran) and Translational Psychiatry Research Group (Bloomfield), University College London; Royal Devon and Exeter NHS Foundation Trust, Exeter, U.K. (Broomby, Price); University College London Hospitals NHS Foundation Trust, London (Coathup, Gilhooly, Gordon-Williams, Brandner); South London and Maudsley NHS Foundation Trust, London (Hill, Harris); Faculty of Medicine, Department of Brain Sciences, Imperial College London (Lingford-Hughes).
出版信息
Am J Psychiatry. 2022 Feb;179(2):152-162. doi: 10.1176/appi.ajp.2021.21030277. Epub 2022 Jan 11.
OBJECTIVE
Early evidence suggests that ketamine may be an effective treatment to sustain abstinence from alcohol. The authors investigated the safety and efficacy of ketamine compared with placebo in increasing abstinence in patients with alcohol use disorder. An additional aim was to pilot ketamine combined with mindfulness-based relapse prevention therapy compared with ketamine and alcohol education as a therapy control.
METHODS
In a double-blind placebo-controlled phase 2 clinical trial, 96 patients with severe alcohol use disorder were randomly assigned to one of four conditions: 1) three weekly ketamine infusions (0.8 mg/kg i.v. over 40 minutes) plus psychological therapy, 2) three saline infusions plus psychological therapy, 3) three ketamine infusions plus alcohol education, or 4) three saline infusions plus alcohol education. The primary outcomes were self-reported percentage of days abstinent and confirmed alcohol relapse at 6-month follow-up.
RESULTS
Ninety-six participants (35 women; mean age, 44.07 years [SD=10.59]) were included in the intention-to-treat analysis. The treatment was well tolerated, and no serious adverse events were associated with the study drug. Although confidence intervals were wide, consistent with a proof-of-concept study, there were a significantly greater number of days abstinent from alcohol in the ketamine group compared with the placebo group at 6-month follow-up (mean difference=10.1%, 95% CI=1.1, 19.0), with the greatest reduction in the ketamine plus therapy group compared with the saline plus education group (15.9%, 95% CI=3.8, 28.1). There was no significant difference in relapse rate between the ketamine and placebo groups.
CONCLUSIONS
This study demonstrated that treatment with three infusions of ketamine was well tolerated in patients with alcohol use disorder and was associated with more days of abstinence from alcohol at 6-month follow-up. The findings suggest a possible beneficial effect of adding psychological therapy alongside ketamine treatment.
目的
早期证据表明，氯胺酮可能是维持戒酒的一种有效治疗方法。作者研究了氯胺酮与安慰剂相比在增加酒精使用障碍患者戒酒率方面的安全性和有效性。另一个目的是对氯胺酮联合基于正念的预防复发疗法与氯胺酮和酒精教育作为治疗对照进行初步试验。
方法
在一项双盲安慰剂对照的2期临床试验中，96名重度酒精使用障碍患者被随机分配到以下四种情况之一：1）每周进行三次氯胺酮静脉输注（0.8毫克/千克，40分钟内输完）加心理治疗；2）三次生理盐水输注加心理治疗；3）三次氯胺酮输注加酒精教育；或4）三次生理盐水输注加酒精教育。主要结局是自我报告的戒酒天数百分比以及6个月随访时确诊的酒精复发情况。
结果
意向性分析纳入了96名参与者（35名女性；平均年龄44.07岁[标准差=10.59]）。治疗耐受性良好，且未发现与研究药物相关的严重不良事件。尽管置信区间较宽，与概念验证研究一致，但在6个月随访时，氯胺酮组戒酒天数明显多于安慰剂组（平均差异=10.1%，95%置信区间=1.1，19.0），氯胺酮加治疗组与生理盐水加教育组相比减少幅度最大（15.9%，95%置信区间=3.8，28.1）。氯胺酮组和安慰剂组的复发率无显著差异。
结论
本研究表明，三次氯胺酮输注治疗在酒精使用障碍患者中耐受性良好，且在6个月随访时与更多的戒酒天数相关。研究结果表明，在氯胺酮治疗的同时加入心理治疗可能有有益效果。
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