Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial.
Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial.
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DOI：
10.1016/s2215-0366(20)30489-2
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发表时间：
2021-04
影响因子：
64.3
通讯作者：
Ries, Richard K.
中科院分区：
文献类型：
--
作者：
Collins, Susan E.;Duncan, Mark H.;Saxon, Andrew J.;Taylor, Emily M.;Mayberry, Nigel;Merrill, Joseph O.;Hoffmann, Gail E.;Clifasefi, Seema L.;Ries, Richard K.
经历无家可归和酒精使用障碍（AUD）的人与酒精相关的死亡率很高，需要获得AUD治疗。然而，典型的基于禁欲的治疗并不能最佳地吸引这一人群。最近的研究表明，旨在减少酒精相关伤害和改善健康相关生活质量（HR-QoL）的低障碍方法更容易为该人群所接受，并且可能有效。本研究的目的是测试药物行为联合减害治疗的有效性。参与者是308名经历无家可归和AUD（80%严重）的成年人，他们被随机分配到4个治疗组：a）AUD（HaRT-A）+缓释纳洛酮（XR-NTX）的行为伤害减少治疗，B）HaRT-A +安慰剂注射，c）仅HaRT-A，和d）照常支持服务（TAU）。所有参与者在基线和第4、8、12、24和36周参加评估。主要结果是自我报告的酒精使用量（AQUA;标准饮料）和频率（ASI），酒精相关的伤害（SIP-2 R）和身体和精神HR-QoL（SF-12）。使用分段生长建模和意向治疗模型，我们测试了3个活性治疗组与TAU相比的效果，以及活性药物与安慰剂相比的效果，双盲组在12周的治疗过程中以及在停药后24周内。与TAU相比，HaRT-A+XR-NTX组在5个主要结局中的4个方面显示了从基线至治疗后12周的统计学显著改善：峰值酒精量（线性B = −.48，CI = −.79，−.18，p = .010），酒精频率（线性B = −4.42，CI = −8.09，− 0.76，p = 0.047），酒精相关伤害（线性B = −2.22，CI = −3.39，−1.06，p = .002）和身体HR-QoL（线性B = .66，CI = .23，1.10，p = .012）。精神HR-QoL的线性治疗效应无统计学显著性（线性B = 1.69，CI = 0.12，3.27，p = 0.076）。在第12周停止治疗后，在36周的随访中保持了改善。比较双盲药物组和安慰剂组的分析显示，任何主要结局均无统计学显著差异。HaRT-A+XR-NTX、HaRT-A +安慰剂和仅HaRT-A的参与者没有报告比TAU参与者更多的不良事件经历。与现有的基于社区的服务相比，联合药物行为减少伤害治疗导致酒精使用和酒精相关伤害减少，并改善了无家可归和AUD患者的身体HR-QoL。考虑到安慰剂与活性药物相比的非显著性影响，合并的药物行为危害减轻治疗效应不能单独归因于药物。未来的研究需要进一步探索这种减少伤害治疗的药理学和行为学成分的相对贡献，并观察维持治疗方法是否可以延长这些积极的结果轨迹。这项研究得到了国家酒精滥用和酒精中毒研究所（1 R 01 AA 022309 -01; PI：柯林斯）的支持。
People experiencing homelessness and alcohol use disorder (AUD) have a high prevalence of alcohol-related mortality and need access to AUD treatment. Typical abstinence-based treatments, however, do not optimally engage this population. Recent research has shown lower-barrier approaches aiming to reduce alcohol-related harm and improve health-related quality of life (HR-QoL) are more acceptable to this population and can be efficacious. This study’s aim was to test the efficacy of combined pharmacobehavioral harm-reduction treatment. Participants were 308 adults experiencing homelessness and AUD (80% severe) who were randomized to 4 treatment arms: a) behavioral Harm-Reduction Treatment for AUD (HaRT-A) + extended-release naltrexone (XR-NTX), b) HaRT-A + placebo injections, c) HaRT-A only, and d) supportive services as usual (TAU). All participants attended assessments at baseline and weeks 4, 8, 12, 24 and 36. Primary outcomes were self-reported alcohol use quantity (AQUA; standard drinks) and frequency (ASI), alcohol-related harm (SIP-2R), and physical and mental HR-QoL (SF-12). Using piecewise growth modeling and an intent-to-treat model, we tested the effects of the 3 active treatment arms compared to TAU and the active medication versus placebo, double-blinded arms over a 12-week treatment course and through the 24 weeks following treatment withdrawal. Compared to TAU, the HaRT-A+XR-NTX arm evinced statistically significant improvements from baseline to 12 weeks posttreatment across 4 of the 5 primary outcomes: peak alcohol quantity (linear B = −.48, CI = −.79, −.18, p = .010), alcohol frequency (linear B = −4.42, CI = −8.09, −.76, p = .047), alcohol-related harm (linear B = −2.22, CI = −3.39, −1.06, p = .002), and physical HR-QoL (linear B = .66, CI = .23, 1.10, p = .012). The linear treatment effect for mental HR-QoL was not statistically significant (linear B = 1.69, CI = .12, 3.27, p = .076). After treatment discontinuation at 12 weeks, improvements were maintained through the 36-week follow-up. Analyses comparing the double-blinded medication and placebo arms showed no statistically significant differences on any of the primary outcomes. HaRT-A+XR-NTX, HaRT-A + Placebo and HaRT-A only participants did not report a greater experience of adverse events than TAU participants. Compared to existing community-based services as usual, combined pharmacobehavioral harm-reduction treatment resulted in decreased alcohol use and alcohol-related harm and improved physical HR-QoL for people experiencing homelessness and AUD. Considering the nonsignificant placebo versus active medication effects, the combined pharmacobehavioral harm-reduction treatment effect cannot be attributed to the medication alone. Future studies are needed to further probe the relative contributions of the pharmacological and behavioral components of this harm-reduction treatment and to see if a maintenance treatment approach can extend these positive outcome trajectories. This research was supported by the National Institute on Alcohol Abuse and Alcoholism (1R01AA022309–01; PI: Collins).