From The Pearson Center for Alcoholism and Addiction Research (BJM), The Scripps Research Institute, La Jolla, CA; and Faculty of Economics (PL), Louvain University, Mons, Belgium.
J Addict Med. 2009 Sep;3(3):164-71. doi: 10.1097/ADM.0b013e3181917d53.
: To evaluate the effect of current smoking and lifetime illicit drug use on alcoholism treatment outcomes and to assess whether these factors influence acamprosate efficacy.
: This is a secondary analysis of data from the intention-to-treat population (N = 601) in a 6-month, randomized, placebo-controlled US trial of acamprosate (2 or 3 g/d). Patients met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria for alcohol dependence and no other dependence disorders other than nicotine or cannabis, although patients with recent substance use were included. Baseline severities of current nicotine dependence and lifetime drug use were determined using the Fagerström test of nicotine dependence and the illicit drug use inventory, respectively. The primary endpoint was rate of good response (abstinence from alcohol for ≥90% of trial). Secondary endpoints were rate of controlled drinking (≤5 drinks/d for ≥90% of trial), percent days abstinent, and percent days controlled drinking. The effect of smoking, drug use, treatment, and any interactions on study endpoints was assessed by a backward selection process to eliminate nonsignificant variables.
: In the intention-to-treat population, 44.9% of patients were current smokers and 78.7% reported lifetime illicit drug use. Current nicotine dependence and lifetime illicit drug use were significant negative predictors of rates of good response (nicotine: odds ratio [OR] = 0.56, 95% confidence interval [CI] = 0.35-0.88, P = 0.01; illicit drugs: OR = 0.47, 95% CI = 0.31-0.71, P < 0.01) and all other secondary outcomes. Acamprosate had a significant positive effect on rate of good response (OR = 1.65, 95% CI = 1.08-2.52, P = 0.020) and all other secondary outcomes.
: Current nicotine dependence and lifetime illicit drug use were found to have a significant negative impact on alcoholism treatment outcomes, but no impact on the significant positive effects of acamprosate. The effect sizes of smoking, drug use, and acamprosate are equivalent and thus, treatment with acamprosate may offset some of the negative effects of smoking or drug use on alcoholism treatment outcomes.
评估当前吸烟和终身非法药物使用对酒精中毒治疗结果的影响，并评估这些因素是否会影响坎普拉西特的疗效。
这是对坎普拉西特（2 或 3 g/d）6 个月、随机、安慰剂对照美国试验意向治疗人群（N=601）数据的二次分析。患者符合精神障碍诊断与统计手册第 4 版酒精依赖标准，且除尼古丁或大麻外，无其他依赖性疾病，尽管包括近期药物使用者。基线尼古丁依赖严重程度和终身药物使用情况分别采用尼古丁依赖性 Fagerström 测试和非法药物使用清单进行确定。主要终点为良好反应率（试验期间≥90%的酒精戒断）。次要终点为控制饮酒率（试验期间≥90%≤5 杯/天）、无饮酒天数百分比和控制饮酒天数百分比。采用向后选择过程评估吸烟、药物使用、治疗和任何相互作用对研究终点的影响，以消除无显著意义的变量。
意向治疗人群中，44.9%的患者为当前吸烟者，78.7%报告有终身非法药物使用史。当前尼古丁依赖和终身非法药物使用是良好反应率的显著负预测因子（尼古丁：优势比[OR] = 0.56，95%置信区间[CI] = 0.35-0.88，P=0.01；非法药物：OR = 0.47，95% CI = 0.31-0.71，P<0.01）和所有其他次要结局。坎普拉西特对良好反应率有显著的积极影响（OR = 1.65，95% CI = 1.08-2.52，P=0.020）和所有其他次要结局。
当前尼古丁依赖和终身非法药物使用对酒精中毒治疗结果有显著的负面影响，但对坎普拉西特的显著积极影响没有影响。吸烟、药物使用和坎普拉西特的效应大小相当，因此，坎普拉西特治疗可能会抵消吸烟或药物使用对酒精中毒治疗结果的一些负面影响。
