Opioid Use Disorder, Pregnancy Related
Conditions
Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
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.
Interventions
BEHAVIORALEmpowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
Two-pronged intervention model: 1) behavioral intervention utilizing interoceptive exposures and cognitive behavioral therapy for insomnia and, 2) mobile application that facilitates medication adherence.
Sponsors
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Buprenorphine retention | 6 months | Prescription drug monitoring program (y/n) |
| Buprenorphine adherence | 6 months | Mobile application data, medication possession ratios (%) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSara Witcraft
Medical University of South Carolina
Outcome results
None listed