Aims To test whether two critical design features, inclusion criteria of required pre-trial abstinence and pre-trial alcohol use disorder (AUD) diagnosis, predict the likelihood of detecting treatment effects in AUD pharmacotherapy trials. Methods This secondary data analysis used data collected from a literature review to identify randomized controlled pharmacotherapy trials for AUD. Treatment outcomes were selected into abstinence and no heavy drinking. Target effect sizes were calculated for each outcome and a meta-regression was conducted to test the effects of required pre-trial abstinence, required pre-trial AUD diagnosis, and their interaction on effect sizes. A sub-analysis was conducted on trials, which included FDA-approved medications for AUD. Results In total, 118 studies testing 19 medications representing 21,032 treated participants were included in the meta-regression analysis. There was no significant effect of either predictor on abstinence or no heavy drinking outcomes in the full analysis or in the sub-study of FDA-approved medications. Conclusion By examining these design features in a quantitative, rather than qualitative, fashion the present study advances the literature and shows that requiring AUD diagnosis or requiring pre-trial abstinence do not impact the likelihood of a significant medication effect in the trial.

中文翻译：

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随机临床试验中预测酒精使用障碍药物治疗对饮酒结果影响的试验特征的元回归：二次数据分析

目的 测试两个关键设计特征，即所需的试验前禁欲和试验前酒精使用障碍 (AUD) 诊断的纳入标准，是否可以预测在 AUD 药物治疗试验中检测治疗效果的可能性。方法 该次要数据分析使用从文献综述中收集的数据来确定 AUD 的随机对照药物治疗试验。治疗结果被选择为戒酒和不酗酒。计算每个结果的目标效应大小，并进行元回归以测试所需的审前禁欲、所需的审前 AUD 诊断以及它们对效应大小的相互作用的影响。对试验进行了子分析，其中包括 FDA 批准的澳元药物。结果总共有 118 项研究测试了代表 21 种药物的 19 种药物，032 名接受治疗的参与者被纳入元回归分析。在全面分析或 FDA 批准的药物的子研究中，这两种预测因子对戒酒或没有重度饮酒结果没有显着影响。结论 通过以定量而非定性的方式检查这些设计特征，本研究推进了文献并表明要求 AUD 诊断或要求试验前禁欲不会影响试验中显着药物效果的可能性。