Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.,Addictive Behaviors

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Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.
Addictive Behaviors ( IF 4.4 ) Pub Date : 2020-07-03 , DOI: 10.1016/j.addbeh.2020.106538
Thomas Kosten ₁ , Efrat Aharonovich ₂ , Narinder Nangia ₃ , Abigail Zavod ₃ , Sarah C Akerman ₃ , Maria Lopez-Bresnahan ₃ , Maria A Sullivan ₄

Affiliation

Background

Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration.

Methods

This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation. Cognition was assessed at baseline, Day 22 (XR-NTX Day 14), and Day 36 (XR-NTX Day 28) using a range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance). Pre-specified exploratory analyses compared treatment groups. Post hoc analyses were treatment-arm–independent analyses overall and by baseline BUP dose (<8 mg/day [low-dose] or 8 mg/day [higher-dose]).

Results

Baseline cognitive measures were similar between NTX/BUP and PBO-N/BUP groups and between BUP low-dose and higher-dose groups. There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed. Participants entering the study on low-dose BUP showed improvements at Day 36 relative to baseline in 5 of 7 cognitive outcomes; participants entering the study on higher-dose BUP generally did not show improvements in cognitive outcomes.

Conclusions

Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.

中文翻译：

阿片类药物使用障碍患者的认知表现从丁丙诺啡过渡到缓释注射纳曲酮：对 3 期随机对照试验探索性结果的事后分析。

背景

阿片类药物使用障碍 (OUD) 与认知功能障碍有关。了解药物治疗如何影响认知是一个重要的治疗考虑因素。

方法

这是一项混合住院-门诊患者随机试验，评估 OUD 患者的过渡方案（纳曲酮/丁丙诺啡 [NTX/BUP] 与安慰剂-NTX/丁丙诺啡 [PBO-N]/BUP）到缓释纳曲酮 (XR-NTX)寻求 BUP 停药。认知在基线、第 22 天（XR-NTX 第 14 天）和第 36 天（XR-NTX 第 28 天）使用一系列措施（认知符号编码测试的简要评估、受控口语联想任务、韦氏记忆量表- III 空间跨度测试、连续性能测试和注意力性能测试）。预先指定的探索性分析比较了治疗组。事后分析是与治疗组无关的总体分析和基线 BUP 剂量（<8 mg/天 [低剂量] 或 8 mg/天 [高剂量]）。

结果

NTX/BUP 和 PBO-N/BUP 组之间以及 BUP 低剂量组和高剂量组之间的基线认知测量值相似。在第 22 天和第 36 天，相对于总体人群的基线，一些认知结果有所改善，但未观察到 NTX/BUP 和 PBO-N/BUP 治疗组之间的差异。参加低剂量 BUP 研究的参与者在第 36 天的 7 项认知结果中有 5 项相对于基线有所改善；参加高剂量 BUP 研究的参与者通常没有表现出认知结果的改善。