Smid Marcela C, Seliski Natasha, Charles Jasmin E, Castro Stephanie, Humiston Grace E, Cash Elysha, Allshouse Amanda, Turner Elizabeth, Carlston Kristi, Gibson Marie, Gordon Adam J, Cochran Gerald T
Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah Health, 30 N. Mario Capecchi Drive, Floor 5 South, Salt Lake City, UT, USA.
Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, USA.
Contemp Clin Trials Commun. 2024 Aug 30;41:101359. doi: 10.1016/j.conctc.2024.101359. eCollection 2024 Oct.
While most pregnant individuals with methamphetamine use disorder (MUD) achieve abstinence, the postpartum period remains a vulnerable time for return to methamphetamine use (MU). Promising data from human and animal models, including three randomized controlled trials, suggest that micronized progesterone may prevent postpartum return to cocaine and nicotine use by reducing cravings. The primary objective of this study is to assess feasibility of enrollment and randomization of postpartum individuals with MUD to micronized progesterone to prevent return to MU. The secondary objectives are to evaluate safety, establish a preliminary estimate of efficacy, and characterize the association between allopregnanolone levels and methamphetamine cravings.
This is a pilot double-blind placebo randomized controlled trial. We plan to enroll 40 postpartum individuals with MUD over 24-months. Individuals, stratified by opioid use disorder (OUD), are randomized 1:1-400 mg oral micronized progesterone daily or placebo and attend weekly study sessions for 12 weeks. Feasibility is measured by achieving 80 % of enrollment goal. Safety is evaluated by side effect frequency, mental health status changes, lactation and medical complications. Efficacy is assessed by comparing proportion of participants with return to MU and time to return to MU based on self-report or urine testing between treatment and control groups. Salivary allopregnanolone levels and methamphetamine cravings are compared between the groups.
Study results will provide a first critical step towards potential intervention for prevention of return to MU among postpartum individuals. Completion of this trial will set the stage for a large-scale efficacy trial.
虽然大多数患有甲基苯丙胺使用障碍（MUD）的孕妇能够实现戒断，但产后时期仍是重新使用甲基苯丙胺（MU）的脆弱阶段。来自人体和动物模型的有前景的数据，包括三项随机对照试验，表明微粉化孕酮可能通过减少渴望来预防产后重新使用可卡因和尼古丁。本研究的主要目的是评估将患有MUD的产后个体纳入微粉化孕酮随机分组以预防重新使用MU的可行性。次要目的是评估安全性、建立疗效的初步估计，并描述别孕烯醇酮水平与甲基苯丙胺渴望之间的关联。
这是一项试点双盲安慰剂随机对照试验。我们计划在24个月内招募40名患有MUD的产后个体。个体按阿片类药物使用障碍（OUD）分层，以1:1的比例随机分配，每天口服400毫克微粉化孕酮或安慰剂，并参加为期12周的每周研究会议。通过达到80%的招募目标来衡量可行性。通过副作用频率、心理健康状况变化、泌乳和医疗并发症来评估安全性。通过比较治疗组和对照组中根据自我报告或尿液检测显示重新使用MU的参与者比例以及重新使用MU的时间来评估疗效。比较两组之间唾液别孕烯醇酮水平和甲基苯丙胺渴望程度。
研究结果将为预防产后个体重新使用MU的潜在干预措施迈出关键的第一步。完成这项试验将为大规模疗效试验奠定基础。
