Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States.
Division of Biostatistics, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, United States.
Drug Alcohol Depend. 2021 Nov 1;228:109031. doi: 10.1016/j.drugalcdep.2021.109031. Epub 2021 Sep 11.
Relapse rates during opioid use disorder (OUD) treatment remain unacceptably high. It is possible that optimally matching patients with medication type would reduce risk of relapse. Our objective was to learn a rule by which to assign type of medication for OUD to reduce risk of relapse, and to estimate the extent to which risk of relapse would be reduced if such a rule were used.
This was a secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial of injection extended-release naltrexone (XR-NTX), delivered approximately every 28 days, or daily sublingual buprenorphine-naloxone (BUP-NX) for treating OUD, 2014-2017 (N = 570). Outcome was a binary indicator of relapse to regular opioid use during the 24 weeks of outpatient treatment.
We found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment.
The number-needed-to-treat with the estimated treatment rule to prevent a single relapse is 14. A simpler, alternative estimated rule in which homeless participants would be treated with XR-NTX and stably housed participants would be treated with BUP-NX performed similarly. These results provide an estimate of the amount by which a relatively simple change in clinical practice could be expected to improve prevention of OUD relapse.
阿片类药物使用障碍（OUD）治疗期间的复发率仍然高得令人无法接受。通过为患者匹配最合适的药物类型，有可能降低复发风险。我们的目标是学习一条规则，通过该规则为 OUD 患者分配药物类型，以降低复发风险，并估计如果使用这样的规则，复发风险将降低多少。
这是对一项为期 24 周的开放性标签随机对照、比较疗效试验的二次分析，该试验比较了每 28 天左右注射一次的纳曲酮延长释放剂（XR-NTX）和每日舌下给予丁丙诺啡-纳洛酮（BUP-NX）治疗 OUD 的效果，该试验于 2014 年至 2017 年进行（N=570）。结果是 24 周门诊治疗期间定期使用阿片类药物的复发的二元指标。
我们发现，应用估计的个体化治疗规则，即根据 OUD 患者的个体特征为其分配 XR-NTX 或 BUP-NX 的规则，使复发风险最小化，与随机分配的治疗相比，24 周时的复发风险可降低 12%。
根据估计的治疗规则，为预防单次复发而需要治疗的人数为 14。另一个更简单的替代估计规则是，将无家可归的参与者用 XR-NTX 治疗，将稳定居住的参与者用 BUP-NX 治疗，效果相似。这些结果提供了一个估计值，表明相对简单的临床实践改变可以预期在预防 OUD 复发方面取得多少效果。
