Objective:

Research has suggested that subanesthetic doses of ketamine may work to improve cocaine-related vulnerabilities and facilitate efforts at behavioral modification. The purpose of this trial was to test whether a single ketamine infusion improved treatment outcomes in cocaine-dependent adults engaged in mindfulness-based relapse prevention.

Methods:

Fifty-five cocaine-dependent individuals were randomly assigned to receive a 40-minute intravenous infusion of ketamine (0.5 mg/kg) or midazolam (the control condition) during a 5-day inpatient stay, during which they also initiated a 5-week course of mindfulness-based relapse prevention. Cocaine use was assessed through self-report and urine toxicology. The primary outcomes were end-of-study abstinence and time to relapse (defined as first use or dropout).

Results:

Overall, 48.2% of individuals in the ketamine group maintained abstinence over the last 2 weeks of the trial, compared with 10.7% in the midazolam group (intent-to-treat analysis). The ketamine group was 53% less likely (hazard ratio=0.47; 95% CI=0.24, 0.92) to relapse (dropout or use cocaine) compared with the midazolam group, and craving scores were 58.1% lower in the ketamine group throughout the trial (95% CI=18.6, 78.6); both differences were statistically significant. Infusions were well tolerated, and no participants were removed from the study as a result of adverse events.

Conclusions:

A single ketamine infusion improved a range of important treatment outcomes in cocaine-dependent adults engaged in mindfulness-based behavioral modification, including promoting abstinence, diminishing craving, and reducing risk of relapse. Further research is needed to replicate these promising results in a larger sample.

中文翻译：

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单次氯胺酮输注结合正念为基础的行为修饰治疗可卡因依赖：一项随机临床试验。

客观的：

研究表明，亚麻醉剂量的氯胺酮可能有助于改善可卡因相关的脆弱性，并促进行为改变的努力。该试验的目的是测试单次氯胺酮输注能否改善可卡因依赖性成年人的正念预防复发的治疗效果。

方法：

55名可卡因依赖者被随机分配为在住院5天期间接受氯胺酮（0.5 mg / kg）或咪达唑仑（对照条件）40分钟静脉输注，在此期间他们还开始了5周基于正念的复发预防过程。可卡因的使用通过自我报告和尿毒理学评估。主要结局是研究结束时的禁欲和复发时间（定义为首次使用或辍学）。

结果：

总体而言，氯胺酮组48.2％的人在试验的最后2周内保持禁欲，而咪达唑仑组则为10.7％（意向性治疗分析）。与咪达唑仑组相比，氯胺酮组复发（辍学或使用可卡因）的可能性（危险比= 0.47； 95％CI = 0.24，0.92）降低了53％，并且在整个试验中，氯胺酮组的渴望得分降低了58.1％ （95％CI = 18.6，78.6）；两种差异均具有统计学意义。输液耐受良好，没有因不良事件而退出研究的参与者。

结论：

单次氯胺酮输注改善了可卡因依赖成年人的一系列重要治疗效果，这些成年人从事基于正念的行为改变，包括促进节欲，减少渴望和降低复发风险。需要进一步的研究以在更大的样本中复制这些有希望的结果。