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| ID | Type | Description | Link |
|---|---|---|---|
| K12DA031794 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder | Experimental | EMPWR is a two-pronged intervention model comprised of 1) a provider-driven, telemedicine-based behavioral intervention to mitigate anxiety sensitivity and sleep deficiency and enhance peripartum buprenorphine retention, and 2) an adjunctive mobile application to promote patients' buprenorphine adherence and use of therapy skills learned through the behavioral intervention. The EMPWR therapy protocol is comprised of five 30-60-minute sessions delivered weekly or biweekly by a therapist during the second and/or third trimester of pregnancy, and three 30-minute booster sessions delivered months 1-3 postpartum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder | Behavioral | Two-pronged intervention model: 1) behavioral intervention utilizing interoceptive exposures and cognitive behavioral therapy for insomnia and, 2) mobile application that facilitates medication adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility | 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) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Buprenorphine retention | Prescription drug monitoring program (y/n) | 6 months |
| Buprenorphine adherence | Mobile application data, medication possession ratios (%) |
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Inclusion Criteria:
Exclusion Criteria:
26 pregnant individuals will be recruited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Sara Witcraft | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2025 | Mar 20, 2026 |
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| 6 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D012893 | Sleep Wake Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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