Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therapy, participants will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. If participants are randomized to medication monitoring, participants will be asked to log each time participants take their medication for two months. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when participants enroll (early second trimester-mid third trimester).
详细描述
Medication for opioid use disorder (MOUD) can effectively prevent overdose and death for pregnant and postpartum people with opioid use disorder (OUD). Yet, only half of birthing people continue to use MOUD postpartum, increasing risk for overdose two-fold. This study will evaluate feasibility of RCT methodology for a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period compared to control (medication monitoring). The intervention contains a brief behavioral intervention targeting malleable risk factors for treatment dropout, opioid cravings, and return to illicit opioid use: anxiety sensitivity and sleep deficiency. An adjunctive mobile application will supplement therapy sessions and contains a medication adherence feature involving daily (or multiple/day) notification reminder to take medication at a scheduled time and dose consistent with the participant's prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •currently pregnant and between 13 weeks and 0 days to 32 weeks and 6 days gestational age
- •current OUD or history of OUD within past 3 years
- •confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD
- •living in the United States
- •between 18-45 years of age
排除标准
- •carrying multiples
- •high-risk pregnancies including the following conditions: active hyperemesis at the time of consent or hospitalization for intractable nausea and vomiting in the current pregnancy, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester
- •current psychotic symptoms and/or active suicidal intent
- •experiencing cognitive or emotional impairment that precludes providing informed consent
- •incarcerated/pending incarceration or institutionalized during the study period
- •non-English speaking.
研究组 & 干预措施
EMPWR
Brief cognitive-behavioral intervention and mobile application
干预措施: Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) (Behavioral)
Control
medication monitoring
干预措施: Medication monitoring (control) (Other)
结局指标
主要结局
Feasibility of Recruitment
时间窗: Years 3-4
Recruitment will be assessed by the proportion of participants who agree to participate in the trial vs. total approached; success is if ≥70% of approached PPP enroll.
Retention in Active Treatment (EMPWR)
时间窗: Years 3-4
Retention will be assessed by the proportion of participants who complete 3- and 6-month postpartum follow-up assessments vs. those who prematurely terminate; success is if 70% of participants are retained for follow-up assessments.
Engagement in intervention
时间窗: Years 3-4
Overall engagement will be measured separately for the EMPWR behavioral intervention and mobile application (EMPWR condition) and daily diary completion (MM condition). To measure engagement in the EMPWR condition, we will consider it successful if 70% of participants attend all EMPWR behavioral intervention sessions, and separately, actively engage with the active components of the mobile application (i.e., 50% days logged buprenorphine, 50% assigned at-home "Practice" exercises completed). In the MM condition, we will consider completing 70% of daily diaries as successful engagement.
次要结局
未报告次要终点
研究者
Sara Witcraft
Research Assistant Professor-Faculty
Medical University of South Carolina