OBJECTIVE The purpose of this study was to investigate if brief treatment for alcohol dependence in primary care with the 15-method was as effective as specialist addiction care. In addition, we sought to investigate trajectories for change of alcohol consumption. METHOD This study was a randomized controlled noninferiority trial, between-groups parallel design, with a noninferiority limit of 50 g of alcohol per week. A total of 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic. The primary outcome was change in weekly alcohol consumption at the 12-month follow-up. Secondary outcomes were heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers. Trajectories were investigated using change in World Health Organization drinking risk levels. RESULTS The intention-to-treat analysis (n = 231) showed that the estimated weekly alcohol consumption in primary care was 18.2 g (95% CI [14.9, 51.3]) higher compared with specialist care (p = .28). Noninferiority was not demonstrated as the confidence interval exceeded the noninferiority limit. The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment. The analyses of trajectories showed the main part of change in consumption occurred from baseline to the 6-month follow-up and was maintained to the 12-month follow-up. CONCLUSIONS Although noninferiority could not be demonstrated, based on similar trajectories and sustained reduction of alcohol use, this study indicates brief treatment of alcohol dependence in primary care with the 15-method is a feasible and promising approach.

中文翻译：

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初级保健中酒精依赖的治疗与门诊专家治疗的比较：十二个月随访的随机对照试验，具有变化的轨迹

目的本研究的目的是调查在15种方法的初级保健中对酒精依赖的简短治疗是否与专业成瘾护理一样有效。此外，我们试图调查酒精消耗变化的轨迹。方法本研究是一项随机对照非劣效性试验，各组之间平行设计，非劣效性限制为每周饮酒50克。共有288位满足ICD-10酒精依赖标准的成年人被随机分配到大学成瘾诊所的初级保健或专科门诊治疗。主要结果是在12个月的随访中每周饮酒量的变化。次要结果是酗酒天数，依赖性严重程度，饮酒后果，心理健康，生活质量，对治疗的满意度，和生物标志物。使用世界卫生组织饮酒风险水平的变化调查了轨迹。结果意向性治疗分析（n = 231）表明，与专科护理相比，初级保健的每周估计酒精消耗量高18.2 g（95％CI [14.9，51.3]）（p = .28）。由于置信区间超过了非劣效性极限，因此未证实非劣效性。次要结果显示，初级护理和专科护理之间没有区别，只是随机分配到专科护理的患者对治疗更满意。轨迹分析表明，消费量变化的主要部分发生在从基线到6个月的随访中，并一直维持到12个月的随访。结论尽管无法证明非自卑，