Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons

Обзор

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).

Подробное описание

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. This study is supported by funding from the NIH HEAL Initiative (https://heal.nih.gov/).

Вмешательства

• Поведенческое Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)
  EMPWR is evidence-informed, behavioral intervention to address risk factors for fear of opioid withdrawal, craving, and stress, with an adjective mobile application among pregnant women receiving opioid agonist therapies. The goal of EMPWR is to promote medication retention and adherence.
• Другое Medication monitoring (control)
  Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text.

Первичные конечные точки

• Feasibility of Recruitment [Срок оценки: Years 3-4]
• Retention in Active Treatment (EMPWR) [Срок оценки: Years 3-4]
• Engagement in intervention [Срок оценки: Years 3-4]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06999811 · Pro00141060 · 1K23DA062794-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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