Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496230
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
EMPWR Pilot Trial Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 biweekly ie once every other week therapy appointments during pregnancy and three 30-minute therapy appointments monthly during the first three months after childbirth 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 and will be contacted approximately once a month to conduct a medication count The total duration of the study is 6 months
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 in this study defined as the third trimester of pregnancy through 3-months postpartum 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 multipleday notification reminder to take medication at a scheduled time and dose consistent with the participants prescription
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K12DA031794 | NIH | None | None |