针对性少数群体男性中轻度至中度酒精使用障碍的靶向口服纳曲酮：一项随机试验。

Targeted Oral Naltrexone for Mild to Moderate Alcohol Use Disorder Among Sexual and Gender Minority Men: A Randomized Trial.

机构信息

Department of Community Health Systems (Santos, Jain), Division of HIV, Infectious Disease, and Global Medicine (Coffin), Department of Psychiatry and Behavioral Sciences (Jain, Batki), and Department of Epidemiology and Biostatistics (Vittinghoff), University of California, San Francisco; Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco (Santos, Ikeda, Coffin, Walker, Matheson, Ali, McLaughlin); Human Services Department, County of Sonoma, Sonoma, California (Arenander); San Francisco VA Health Care System, San Francisco (Batki).

出版信息

Am J Psychiatry. 2022 Dec 1;179(12):915-926. doi: 10.1176/appi.ajp.20220335. Epub 2022 Oct 26.

DOI:10.1176/appi.ajp.20220335

PMID:36285404

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10072332/

Abstract

OBJECTIVE

The authors sought to determine the efficacy of targeted naltrexone in sexual and gender minority men (SGM) who binge drink and have mild to moderate alcohol use disorder.

METHODS

In a double-blind placebo-controlled trial, a total of 120 SGM who binge drink and have mild to moderate alcohol use disorder were randomized in a 1:1 ratio to receive targeted oral naltrexone (50 mg) or placebo with weekly counseling for 12 weeks. The study's primary endpoints were binge-drinking intensity, defined as 1) number of drinks in the past 30 days; 2) any binge drinking in the past week; 3) number of binge-drinking days in the past week; and 4) number of drinking days in the past week. The study also measured changes in alcohol use with two alcohol biomarker measures: ethyl glucuronide in urine samples and phosphatidylethanol (PEth) in dried blood spot samples.

RESULTS

Ninety-three percent completed the trial, with 85% of weekly follow-up visits completed. In intention-to-treat analyses, naltrexone was associated with a significantly reduced reported number of binge-drinking days (incidence rate ratio [IRR]=0.74, 95% CI=0.56, 0.98; number needed to treat [NNT]=2), weeks with any binge drinking (IRR=0.83, 95% CI=0.72, 0.96; NNT=7.4), number of drinks per month (IRR=0.69, 95% CI=0.52, 0.91; NNT=5.7 for 10 drinks), and alcohol craving scores (coefficient=-9.25, 95% CI=-17.20, -1.31). In as-treated analyses among those who took their medication on average at least 2.5 days per week (the median frequency in the study), naltrexone reduced any binge drinking (IRR=0.84, 95% CI=0.71, 0.99), number of binge-drinking days (IRR=0.67, 95% CI=0.47, 0.96), and PEth concentrations (coefficient=-55.47, 95% CI=-110.75, -0.20). At 6 months posttreatment, naltrexone had sustained effects in number of drinks per month (IRR=0.69, 95% CI=0.50, 0.97), number of binge-drinking days (IRR=0.67, 95% CI=0.47, 0.95), and any binge drinking in the past week (IRR=0.79, 95% CI=0.63, 0.99).

CONCLUSIONS

Targeted naltrexone significantly reduced drinking outcomes among SGM with mild to moderate alcohol use disorder during treatment, with sustained effects at 6 months posttreatment. Naltrexone may be an important pharmacotherapy to address binge drinking in populations with mild to moderate alcohol use disorder.

摘要

目的

作者旨在确定针对有轻度至中度酒精使用障碍且 binge drink 的性少数群体男性（SGM）的靶向纳曲酮的疗效。

方法

在一项双盲安慰剂对照试验中，120 名有 binge drink 且有轻度至中度酒精使用障碍的 SGM 被随机分为 1:1 比例，分别接受靶向口服纳曲酮（50mg）或安慰剂，并在 12 周内每周接受一次咨询。该研究的主要终点是 binge-drinking 强度，定义为 1）过去 30 天内的饮酒量；2）过去一周内的任何 binge drinking；3）过去一周内 binge-drinking 的天数；4）过去一周内的饮酒天数。该研究还通过两种酒精生物标志物测量来衡量酒精使用的变化：尿液样本中的乙基葡糖苷酸和干血斑样本中的磷脂酰乙醇（PEth）。

结果

93%的参与者完成了试验，85%的人完成了每周的随访。在意向治疗分析中，纳曲酮与报告的 binge-drinking 天数显著减少相关（发生率比[IRR]=0.74，95%置信区间[CI]=0.56，0.98；需要治疗的人数[NNT]=2），有任何 binge drinking 的周数（IRR=0.83，95%CI=0.72，0.96；NNT=7.4），每月饮酒量（IRR=0.69，95%CI=0.52，0.91；NNT=5.7 杯）和酒精渴求评分（系数=-9.25，95%CI=-17.20，-1.31）。在平均每周至少服用药物 2.5 天的治疗分析中（研究中的中位数频率），纳曲酮减少了任何 binge drinking（IRR=0.84，95%CI=0.71，0.99）、 binge-drinking 天数（IRR=0.67，95%CI=0.47，0.96）和 PEth 浓度（系数=-55.47，95%CI=-110.75，-0.20）。在治疗后 6 个月时，纳曲酮对每月饮酒量（IRR=0.69，95%CI=0.50，0.97）、 binge-drinking 天数（IRR=0.67，95%CI=0.47，0.95）和过去一周内任何 binge drinking（IRR=0.79，95%CI=0.63，0.99）均有持续的效果。