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.

中文翻译：

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辅助性氯胺酮与基于复发预防的心理疗法治疗酒精使用障碍

客观的：

早期证据表明，氯胺酮可能是维持戒酒的有效治疗方法。作者调查了氯胺酮与安慰剂相比在增加酒精使用障碍患者戒酒方面的安全性和有效性。另一个目标是将氯胺酮与基于正念的复发预防疗法相结合，并将氯胺酮和酒精教育作为治疗控制。

方法：

在一项双盲安慰剂对照的 2 期临床试验中，96 名患有严重酒精使用障碍的患者被随机分配到以下四种情况之一：1）每周 3 次氯胺酮输注（0.8 mg/kg iv 超过 40 分钟）加心理治疗，2 ) 3 次生理盐水输注加心理治疗，3) 3 次氯胺酮输注加酒精教育，或 4) 3 次生理盐水输注加酒精教育。主要结果是自我报告的戒酒天数百分比，并在 6 个月的随访中确认酒精复发。

结果：

96 名参与者（35 名女性；平均年龄，44.07 岁 [SD=10.59]）被纳入意向治疗分析。该治疗耐受性良好，并且没有与研究药物相关的严重不良事件。尽管置信区间很宽，与概念验证研究一致，但在 6 个月的随访中，与安慰剂组相比，氯胺酮组的戒酒天数显着增加（平均差异 = 10.1%， 95% CI=1.1, 19.0)，与生理盐水加教育组相比，氯胺酮加治疗组的降幅最大（15.9%, 95% CI=3.8, 28.1）。氯胺酮组和安慰剂组的复发率没有显着差异。

结论：

这项研究表明，酒精使用障碍患者对氯胺酮的 3 次输注治疗耐受性良好，并且在 6 个月的随访中与更多天数的戒酒有关。研究结果表明，在氯胺酮治疗的同时增加心理治疗可能会产生有益的影响。