Weiss Roger D, Rao Vinod
Division of Alcohol and Drug Abuse, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA.
Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Partners HealthCare Addiction Psychiatry Fellowship, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
Drug Alcohol Depend. 2017 Apr 1;173 Suppl 1(Suppl 1):S48-S54. doi: 10.1016/j.drugalcdep.2016.12.001.
The multi-site Prescription Opioid Addiction Treatment Study (POATS), conducted by the National Drug Abuse Treatment Clinical Trials Network, was the largest clinical trial yet conducted with patients dependent upon prescription opioids (N=653). In addition to main trial results, the study yielded numerous secondary analyses, and included a 3.5-year follow-up study, the first of its kind with this population. This paper reviews key findings from POATS and its follow-up study.
The paper summarizes the POATS design, main outcomes, predictors of outcome, subgroup analyses, the predictive power of early treatment response, and the long-term follow-up study.
POATS examined combinations of buprenorphine-naloxone of varying duration and counseling of varying intensity. The primary outcome analysis showed no overall benefit to adding drug counseling to buprenorphine-naloxone and weekly medical management. Only 7% of patients achieved a successful outcome (abstinence or near-abstinence from opioids) during a 4-week taper and 8-week follow-up; by comparison, 49% of patients achieved success while subsequently stabilized on buprenorphine-naloxone. Long-term follow-up results were more encouraging, with higher abstinence rates than in the main trial. Patients receiving opioid agonist treatment at the time of follow-up were more likely to have better outcomes, though a sizeable number of patients succeeded without agonist treatment. Some patients initiated risky use patterns, including heroin use and drug injection. A limitation of the long-term follow-up study was the low follow-up rate.
POATS was the first large-scale study of the treatment of prescription opioid dependence; its findings can influence both treatment guidelines and future studies.
由国家药物滥用治疗临床试验网络开展的多中心处方阿片类药物成瘾治疗研究(POATS),是针对处方阿片类药物依赖患者开展的规模最大的临床试验(N = 653)。除主要试验结果外,该研究还进行了大量的二次分析,并开展了一项为期3.5年的随访研究,这在该人群中尚属首次。本文回顾了POATS及其随访研究的主要发现。
本文总结了POATS的设计、主要结局、结局预测因素、亚组分析、早期治疗反应的预测能力以及长期随访研究。
POATS研究了不同疗程的丁丙诺啡 - 纳洛酮组合以及不同强度的咨询服务。主要结局分析表明,在丁丙诺啡 - 纳洛酮及每周一次的医疗管理基础上增加药物咨询并无总体益处。在为期4周的减药期和8周的随访期内,只有7%的患者取得了成功结局(阿片类药物戒断或接近戒断);相比之下,49%的患者在随后使用丁丙诺啡 - 纳洛酮维持治疗时取得了成功。长期随访结果更令人鼓舞,戒断率高于主要试验。随访时接受阿片类激动剂治疗的患者更有可能获得更好的结局,不过仍有相当数量的患者在未接受激动剂治疗的情况下取得了成功。一些患者开始出现危险的使用模式,包括使用海洛因和注射毒品。长期随访研究的一个局限性是随访率较低。
POATS是第一项关于处方阿片类药物依赖治疗的大规模研究;其研究结果可影响治疗指南和未来研究。