Clinical trial NCT06999811: Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Official title: Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Pregnancy
Keywords: Anxiety
Mental Health
Pregnancy
Psychiatry
Sleep Disorders
Substance Use
Women&#39;s Health
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-31
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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, (d) living in the United States
* between 18-45 years of age. Patients may be prescribed buprenorphine prior to their pregnancy or initiate buprenorphine during their pregnancy.

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. Participants may be excluded if they have a medical condition for which interoceptive exposures may be contraindicated; if needed, the study medical physician will determine whether the participant is medically eligible (see section 10.c.).

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: Years 3-4
measure: Retention in Active Treatment (EMPWR)
timeFrame: Years 3-4
measure: Engagement in intervention
timeFrame: Years 3-4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Sara Witcraft
role: PRINCIPAL_INVESTIGATOR
References: