Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms A Randomized Clinical Trial
Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms A Randomized Clinical Trial
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DOI：
10.1001/jamainternmed.2020.0249
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发表时间：
2020-05-01
影响因子：
39
通讯作者：
Bristol, Emily
中科院分区：
文献类型：
--
作者：
Anton, Raymond F.;Latham, Patricia;Bristol, Emily
虽然估计有3000万人符合酒精使用障碍（AUD）的标准，但很少有人接受适当的药物治疗。更加个性化、针对症状的方法可能会提高疗效和接受度。目的探讨加巴喷丁对酒精依赖性听力损失（AUD）的治疗作用，尤其是对伴有酒精戒断症状的患者。设计，设置和参与者这项双盲随机临床试验于2014年11月至2018年6月进行，在16周的治疗期内，在学术门诊环境中筛选和治疗的社区招募参与者中评估了加巴喷丁与安慰剂。共筛选了145名符合精神疾病诊断和统计手册（第五版）AUD标准且未接受其他AUD干预的寻求治疗的个体，96名符合近期戒酒标准的个体在戒酒3天后随机接受治疗。记录每日饮酒量，并在基线和治疗期间每月收集血液中二唾液酸碳水化合物缺乏型转铁蛋白（重度饮酒标志物）的百分比。干预加巴喷丁高达1200 mg/d，口服，与安慰剂沿着9次医疗管理访视（每次20分钟）。主要结果和测量：在治疗组之间比较了没有大量饮酒日和完全戒酒的个体的百分比，并根据研究前的酒精戒断症状进行了进一步评估。结果在96名随机化个体中，90名可评价（加巴喷丁组44名，安慰剂组46名），平均（SD）年龄为49.6（10.1）岁; 69名男性（77%），85名白色（94%）。可评估的参与者有83%的基线重度饮酒日（女性每天4杯或更多，男性5杯或更多），并符合精神疾病诊断和统计手册（第五版）的4.5酒精戒断标准。更多加巴喷丁治疗的个体没有大量饮酒的日子（44名参与者中的12名[27%]）与安慰剂相比（46名参与者中有4名[9%]），差异为18.6%（95% CI，3.1-34.1; P = .02;需要治疗的人数[NNT]，5.4），以及更多的完全禁欲（8/44 [18%]）与安慰剂（2/46 [4%]）相比，差异为13.8%（95% CI，1.0-26.7; P = 0.04; NNT，6.2）。与安慰剂组相比，研究前高酒精戒断组在无重度饮酒天数（P <0.02; NNT，3.1）和完全戒酒（P = 0.003; NNT，2.7）方面具有积极的加巴喷丁效应，而在低酒精戒断组中，没有显著差异。这些发现与其他饮酒变量相似，仅在高度酒精戒断组中加巴喷丁比安慰剂更有效。加巴喷丁引起更多的头晕，但这并不影响疗效。结论和相关性这些数据，结合其他数据，表明加巴喷丁可能是最有效的人与AUD和酒精戒断症状的历史。未来的研究应评估睡眠的变化和情绪在早期恢复作为中介的加巴喷丁efficacy.Question是加巴喷丁有效的治疗酒精使用障碍的成年人的酒精戒断症状的历史？结果在这项随机临床试验中，加巴喷丁与安慰剂相比，显着增加了总禁欲和减少饮酒的人数。这种效果在治疗前酒精戒断症状更严重的患者中观察到最明显--41%的酒精戒断症状严重的参与者对加巴喷丁完全戒断，而1%的参与者对加巴喷丁完全戒断。这项研究表明，加巴喷丁在促进戒酒和减少酒精使用障碍患者的饮酒方面是有效的，特别是在那些有更多酒精戒断的人中。该随机临床试验检验了加巴喷丁作为药物疗法对具有酒精戒断史的成人酒精使用障碍的疗效。
Importance Although an estimated 30 million people meet criteria for alcohol use disorder (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, approach might improve efficacy and acceptance. Objective To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms. Design, Setting, and Participants This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment. Interventions Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each). Main Outcomes and Measures The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms. Results Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high-alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low-alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy. Conclusions and Relevance These data, combined with others, suggest gabapentin might be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future studies should evaluate sleep changes and mood during early recovery as mediators of gabapentin efficacy.Question Is gabapentin efficacious in the treatment of alcohol use disorder in adults with a history of alcohol withdrawal symptoms? Findings In this randomized clinical trial, gabapentin compared with placebo significantly increased the number of people with total abstinence and reduced drinking. This effect was most significantly observed in those with greater pretreatment alcohol withdrawal symptoms-41% of participants with high alcohol withdrawal symptoms had total abstinence on gabapentin compared with 1% of participants in the placebo arm. Meaning This study showed that gabapentin is efficacious in promoting abstinence and reducing drinking in individuals with alcohol use disorder and especially so in those with more alcohol withdrawal symptoms.This randomized clinical trial examines the efficacy of gabapentin as pharmacotherapy for alchohol use disorder in adults with a history of alcohol withdrawal.