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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Opioid Use Disorder; Pregnancy

Treatments: Other: Medication monitoring (control); Behavioral: Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06999811

1K23DA062794-01 (Other Grant/Funding Number)

Pro00141060

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 37 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

EMPWR

Experimental group

Description:

Brief cognitive-behavioral intervention and mobile application

Treatment:

Behavioral: Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)

Control

Active Comparator group

Description:

medication monitoring

Treatment:

Other: Medication monitoring (control)