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纳曲酮和安非他酮联合治疗方案治疗人类饮酒狂欢症的初步开放性研究。

A Preliminary, Open-Label Study of Naltrexone and Bupropion Combination Therapy for Treating Binge Drinking in Human Subjects.

机构信息

Pharmacology Department, University of North Carolina, 120 Mason Farm Road, 4010 Genetic Medicine Building, Campus Box 7365, Chapel Hill, NC 27514, USA.

Psychology & Neuroscience Department, University of North Carolina, 235 E Cameron Ave, Chapel Hill, NC 27599, USA.

出版信息

Alcohol Alcohol. 2020 Feb 7;55(1):56-62. doi: 10.1093/alcalc/agz076.

Abstract

AIMS

The combination of bupropion and naltrexone has shown efficacy in reducing binge drinking in animal models. This study assessed the tolerability and potential utility of combined naltrexone and bupropion in reducing binge drinking in human subjects.

METHODS

This preliminary study employed an open-label, single-arm, 12-week, prospective design. Twelve men and women who exhibited a minimum of five (men) or three (women) binge drinking episodes per month over the past 3 months were recruited. All subjects received both bupropion-extended release 300 mg/day and naltrexone 50 mg/day and were monitored throughout the 3-month treatment period. Binge drinking was assessed using the timeline follow-back method.

RESULTS

Treatment with combined naltrexone and bupropion reduced the average number of drinks per binge drinking day from 7.8 drinks to 6.4 drinks and reduced the average percentage of binge drinking days per month from 19% (5.7 days/month) to 5% (1.5 days/month). Naltrexone and bupropion were generally well tolerated, with insomnia, headache and nausea/diarrhea being the most common side effects. Six subjects elected to stay on medication after the trial.

CONCLUSIONS

This study suggests that combined naltrexone and bupropion therapy should be further investigated for tolerability and efficacy in reducing binge drinking in humans.

摘要

目的

丁丙诺啡与纳曲酮联合使用已在动物模型中显示出减少 binge drinking 的疗效。本研究评估了联合使用纳曲酮和安非他酮在减少人类 binge drinking 方面的耐受性和潜在效用。

方法

本初步研究采用开放标签、单臂、12 周、前瞻性设计。招募了过去 3 个月中每月至少有 5 次(男性)或 3 次(女性) binge drinking 发作的 12 名男性和女性受试者。所有受试者均接受安非他酮缓释片 300mg/天和纳曲酮 50mg/天治疗,并在整个 3 个月治疗期间接受监测。通过时间线回溯法评估 binge drinking。

结果

联合使用纳曲酮和安非他酮治疗将 binge drinking 日的平均饮酒量从 7.8 杯减少到 6.4 杯,将每月 binge drinking 日的平均百分比从 19%(5.7 天/月)减少到 5%(1.5 天/月)。纳曲酮和安非他酮通常具有良好的耐受性,最常见的副作用是失眠、头痛和恶心/腹泻。6 名受试者在试验后选择继续服药。

结论

本研究表明,联合使用纳曲酮和安非他酮治疗应该进一步研究其在减少人类 binge drinking 方面的耐受性和疗效。

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