Haass-Koffler Carolina L, Piacentino Daria, Li Xiaobai, Long Victoria M, Lee Mary R, Swift Robert M, Kenna George A, Leggio Lorenzo
From the Department of Psychiatry and Human Behavior (CLH-K, RMS, GAK), Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island.
Department of Behavioral and Social Sciences (CLH-K, VML, LL), Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, Rhode Island.
Alcohol Clin Exp Res. 2020 Oct;44(10):2097-2108. doi: 10.1111/acer.14428. Epub 2020 Sep 30.
One of the challenges in early-stage clinical research aimed at developing novel treatments for alcohol use disorder (AUD) is that the enrolled participants are heavy drinkers, but do not seek treatment for AUD.
To compare nontreatment seekers with alcohol dependence (AD) from 4 human laboratory studies conducted at Brown University (N = 240; 65.4% male) to treatment seekers with AD from the multisite COMBINE study (N = 1,383; 69.1% male) across sociodemographic and alcohol-related clinical variables and to evaluate whether the variables that significantly differentiate the 2 samples predict the 3 main COMBINE clinical outcomes: time to relapse, percent days abstinent (PDA), and good clinical outcome.
Sample characteristics were assessed by parametric and nonparametric testing. Three regression models measured the association between the differing variables and the 3 main COMBINE clinical outcomes.
The nontreatment seekers, compared to the treatment seekers, were more ethnically diverse, less educated, single, and working part-time or unemployed (p's < 0.05); they met fewer DSM-IV AD criteria and had significantly lower scores on alcohol-related scales (p's < 0.05); they were less likely to have a father with alcohol problems (p < 0.0001) and had a significantly earlier age of onset and longer duration of AD (p's < 0.05); they also had significantly more total drinks, drinks per drinking day, heavy drinking days (HDD), and lower PDA in the 30 days prior to baseline (p's < 0.0001 to <0.05). Having more HDD in the 30 days prior to baseline predicted all of the 3 COMBINE clinical outcomes. All the other characteristics mentioned above that differed significantly between the 2 groups predicted at least 1 of the 3 COMBINE clinical outcomes, except for level of education, age of onset, and duration of AD.
The observed differences between groups should be considered in efforts across participant recruitment at different stages of the development of new treatments for AUD.
旨在开发酒精使用障碍(AUD)新疗法的早期临床研究面临的挑战之一是,入组参与者为重度饮酒者,但并未寻求AUD治疗。
在布朗大学开展的4项人体实验室研究(N = 240;65.4%为男性)中,将未寻求治疗的酒精依赖(AD)者与多中心联合研究(COMBINE study)中寻求治疗的AD者(N = 1383;69.1%为男性)在社会人口统计学和酒精相关临床变量方面进行比较,并评估显著区分这两个样本的变量是否能预测联合研究的3个主要临床结局:复发时间、戒酒天数百分比(PDA)和良好临床结局。
通过参数检验和非参数检验评估样本特征。三个回归模型测量了不同变量与联合研究的3个主要临床结局之间的关联。
与寻求治疗者相比,未寻求治疗者种族更多样化,受教育程度更低,单身,从事兼职工作或失业(p值<0.05);他们符合的DSM-IV酒精依赖标准更少,在酒精相关量表上的得分显著更低(p值<0.05);他们的父亲有酒精问题的可能性更小(p<0.0001),AD发病年龄显著更早且病程更长(p值<0.05);在基线前30天,他们的总饮酒量、每日饮酒量、重度饮酒天数(HDD)也显著更多,PDA更低(p值<0.0001至<0.05)。基线前30天HDD更多可预测联合研究的所有三个临床结局。两组之间上述所有其他显著不同的特征至少可预测联合研究的三个临床结局之一,但受教育程度、发病年龄和AD病程除外。
在开发AUD新疗法的不同阶段进行参与者招募时,应考虑到观察到的组间差异。