Department for Psychology, The City College of New York, New York, NY, USA.
Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, USA; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Drug Alcohol Depend. 2023 Jul 1;248:109918. doi: 10.1016/j.drugalcdep.2023.109918. Epub 2023 May 12.
The selection of appropriate efficacy endpoints in clinical trials has been a long-standing challenge for the substance use disorder field. Using data from a large, multi-site National Drug Abuse Treatment Clinical Trials Network trial (CTN-0044; n=474), this secondary data analysis aimed to explore whether specific proximal (during-treatment) substance use outcome measures predict longer-term improvements in psychosocial functioning and post-treatment abstinence, and whether predictions vary depending on the specific substance (cannabis, cocaine/stimulants, opioids, and alcohol).
Generalized linear mixed models examined associations between six during-treatment substance use outcome measures and social functioning impairment (Social Adjustment Scale Self-Report) and severity of psychiatric symptoms (Brief Symptom Inventory-18) at end-of-treatment, and 3- and 6-months after treatment as well as post-treatment abstinence.
Maximum days of consecutive abstinence, proportion of days abstinent, ≥3 weeks of continuous abstinence, and the proportion of urine specimens negative for the primary substance were associated with post-treatment psychiatric and social functioning improvement and abstinence. However, only the effects of abstinence during the last 4 weeks of the treatment period on all three post-treatment outcomes was stable over time and did not differ between primary substance groups. In contrast, complete abstinence during the 12-week treatment period was not consistently associated with functioning improvements.
Substance use outcome measures capturing the duration of primary substance abstinence during treatment are suitable predictors of post-treatment abstinence and longer-term psychosocial functioning improvement. Binary outcomes, such as end-of-treatment abstinence, may be particularly stable predictors and attractive given their ease of computation and straightforward clinical interpretability.
在临床研究中选择合适的疗效终点一直是药物滥用领域的一个长期挑战。本研究利用来自一个大型多中心国家药物滥用治疗临床试验网络（CTN-0044；n=474）的研究数据，旨在探讨特定的近期（治疗期间）物质使用结果指标是否能预测更长期的心理社会功能改善和治疗后戒断，以及预测是否因具体物质（大麻、可卡因/兴奋剂、阿片类药物和酒精）而异。
采用广义线性混合模型，考察了 6 项治疗期间物质使用结果指标与治疗结束时社会功能障碍（社会适应量表自评）和精神症状严重程度（Brief Symptom Inventory-18），以及治疗后 3 个月和 6 个月和治疗后戒断之间的关系。
连续无毒品使用天数、无毒品使用天数比例、≥3 周连续无毒品使用天数和主要物质尿液样本阴性比例与治疗后精神和社会功能改善及戒断有关。然而，只有治疗最后 4 周的戒断对所有 3 项治疗后结局的影响在时间上是稳定的，且在主要物质组之间没有差异。相比之下，治疗期 12 周内完全戒断与功能改善并不始终相关。
反映治疗期间主要物质戒断持续时间的物质使用结果指标是治疗后戒断和更长期心理社会功能改善的合适预测指标。在考虑到其易于计算和直接的临床可解释性的情况下，如治疗结束时的戒断等二分法结局可能是特别稳定的预测指标。
