Li Michael J, Chau Brendon, Belin Thomas, Carmody Thomas, Jha Manish K, Marino Elise N, Trivedi Madhukar, Shoptaw Steven J
Center for Behavioral and Addiction Medicine, University of California, Los Angeles, Los Angeles, California, USA.
Department of Family Medicine, University of California, Los Angeles, Los Angeles, California, USA.
Addiction. 2024 Oct;119(10):1840-1845. doi: 10.1111/add.16529. Epub 2024 Jun 10.
A 12-week placebo-controlled, sequential parallel Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT-2) trial evaluated the effects of extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN) on methamphetamine (MA) use over two stages. This study reports on the previously unpublished stage 2 MA use in participants randomized at stage 1 to receive NTX + BUPN through both stages compared with those assigned to placebo.
This is a secondary analysis of the US National Institute on Drug Abuse (NIDA) ADAPT-2 network trial.
The parent ADAPT-2 trial was carried out across multiple NIDA Clinical Trials Network (CTN) sites in the United States.
This analysis includes 403 people with MA use disorder who participated in the ADAPT-2 CTN trial.
NTX + BUPN was compared with placebo over the course of the trial.
MA use was measured by urine drug screens conducted twice weekly for 12 weeks, then once in week 13 and once in week 16 post-treatment follow-up.
Participants on NTX + BUPN in stage 1 showed an additional 9.2% increase [95% confidence interval (CI), 0.09%-17.9%, P = 0.038] during stage 2 in their probability of testing negative for MA, with a total increase of 27.1% (95% CI, 13.2%-41.1%, P < 0.001) over the full 12 weeks of treatment. In contrast, participants on placebo in both stages increased in probability of testing MA-negative by a total of 11.4% (95% CI, 4.1%-18.6%, P = 0.002) over all 12 weeks. The 12-week increase among participants on NTX + BUPN was significantly greater-by 15.8% (95% CI, 4.5%-27.0%, P = 0.006)-than the increase among those on placebo.
For people with methamphetamine (MA) use disorder receiving treatment with extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN), continued treatment with NTX + BUPN after 6 weeks is associated with additional reductions in MA use up to 12 weeks.
一项为期12周的安慰剂对照、序贯平行的甲基苯丙胺使用障碍药物辅助治疗加速开发试验（ADAPT - 2），分两个阶段评估了长效注射用纳曲酮加长效口服安非他酮（NTX + BUPN）对甲基苯丙胺（MA）使用的影响。本研究报告了在第1阶段随机分组接受两个阶段均为NTX + BUPN治疗的参与者中，之前未发表的第2阶段MA使用情况，并与分配接受安慰剂治疗的参与者进行比较。
这是对美国国立药物滥用研究所（NIDA）ADAPT - 2网络试验的二次分析。
ADAPT - 2原始试验在美国多个NIDA临床试验网络（CTN）站点进行。
本分析包括403名患有MA使用障碍并参与ADAPT - 2 CTN试验的人。
在整个试验过程中，将NTX + BUPN与安慰剂进行比较。
通过每周进行两次、为期12周的尿液药物筛查来测量MA使用情况，然后在治疗后第13周和第16周各进行一次测量。
在第1阶段接受NTX + BUPN治疗的参与者在第2阶段MA检测呈阴性的概率额外增加了9.2%[95%置信区间（CI），0.09% - 17.9%，P = 0.038]，在整个12周的治疗过程中总体增加了27.1%（95% CI，13.2% - 41.1%，P < 0.001）。相比之下，两个阶段均接受安慰剂治疗的参与者在整个12周内MA检测呈阴性的概率总共增加了11.4%（95% CI，4.1% - 18.6%，P = 0.002）。接受NTX + BUPN治疗的参与者在12周内的增加幅度比接受安慰剂治疗的参与者显著高出15.8%（95% CI，4.5% - 27.0%，P = 0.006）。
对于接受长效注射用纳曲酮加长效口服安非他酮（NTX + BUPN）治疗的甲基苯丙胺（MA）使用障碍患者，6周后继续使用NTX + BUPN治疗与MA使用量在12周内进一步减少相关。
