Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People
- Conditions
- Pregnancy RelatedOpioid Use Disorder
- Interventions
- Behavioral: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
- Registration Number
- NCT06496230
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.
- 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 acceptability of a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 26
- Currently pregnant and less than 33 weeks gestational age,
- 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.
- Carrying multiples (i.e., twins, triplets, etc.);
- High-risk pregnancies including the following conditions: hyperemesis defined as hospitalization for intractable nausea and vomiting, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder EMPWR is a two-pronged intervention model developed for pregnant and postpartum people with opioid use disorder that is comprised of 1) a provider-driven, telemedicine-based behavioral intervention to enhance medication for opioid use disorder (MOUD) retention; and 2) an adjunctive mobile application to promote patients' MOUD adherence and use of therapy skills. The EMPWR therapy protocol is comprised of four 60-minute sessions delivered biweekly by a therapist during the third trimester of pregnancy, and three booster sessions postpartum.
- Primary Outcome Measures
Name Time Method Intervention Feasibility 1 year Feasibility of the intervention (e.g., Recruitment: 20 pregnant women with OUD prescribed buprenorphine; Study retention: ≥50% participants retained through 3-month postpartum assessment; Protocol adherence: ≥50% attend all EMPWR therapy sessions;145 Satisfaction: qualitative feedback to assess what participants liked/did not like about the intervention)
- Secondary Outcome Measures
Name Time Method Buprenorphine retention 6 months Prescription drug monitoring program (y/n)
Buprenorphine adherence 6 months Mobile application data, medication possession ratios (%)
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States