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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA062794-01 | 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 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).
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. This study is supported by funding from the NIH HEAL Initiative (https://heal.nih.gov/).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMPWR | Experimental | Brief cognitive-behavioral intervention and mobile application |
|
| Control | Active Comparator | medication monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) | Behavioral | EMPWR is evidence-informed, behavioral intervention to address risk factors for fear of opioid withdrawal, craving, and stress, with an adjective mobile application among pregnant women receiving opioid agonist therapies. The goal of EMPWR is to promote medication retention and adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Recruitment will be assessed by the proportion of participants who agree to participate in the trial vs. total approached; success is if ≥70% of approached PPP enroll. | Years 3-4 |
| Retention in Active Treatment (EMPWR) | Retention will be assessed by the proportion of participants who complete 3- and 6-month postpartum follow-up assessments vs. those who prematurely terminate; success is if 70% of participants are retained for follow-up assessments. | Years 3-4 |
| Engagement in intervention | Overall engagement will be measured separately for the EMPWR behavioral intervention and mobile application (EMPWR condition) and daily diary completion (MM condition). To measure engagement in the EMPWR condition, we will consider it successful if 70% of participants attend all EMPWR behavioral intervention sessions, and separately, actively engage with the active components of the mobile application (i.e., 50% days logged buprenorphine, 50% assigned at-home "Practice" exercises completed). In the MM condition, we will consider completing 70% of daily diaries as successful engagement. | Years 3-4 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant people with opioid use disorder (OUD) receiving buprenorphine formulations
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morgan Thomas | Contact | 843-998-4211 | thomamor@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara Witcraft | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29403 | United States |
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| Medication monitoring (control) | Other | Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text. |
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| 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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