Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04584502
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mindful Moms in Recovery
Sponsor:
Trustees of Dartmouth College
Organization:
Study Overview
Official Title:
Mindful Moms in Recovery: Yoga-based Mindfulness Relapse Prevention for Pregnant Women With Opioid Use Disorder
Status:
COMPLETED
Status Verified Date:
2025-07
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:
MMORE
Brief Summary:
The purpose of this study is to evaluate the initial efficacy of a yoga-mindfulness intervention to promote ongoing recovery for pregnant and parenting women with Opioid Use Disorder (OUD) receiving perinatal services and medication treatment for OUD from maternity care practices in New Hampshire.
Detailed Description:
In this R33 project, the study team will conduct a randomized controlled trial to evaluate the efficacy and implementation of the Mindful Moms intervention (MMORE) with a group of pregnant women with identified OUD receiving medication treatment for OUD at partner maternity care practices. The study team will evaluate the impact of Mindful Moms as an adjunct to treatment as usual on retention in medication for opioid use disorder (MOUD) treatment, substance use, and relapse-related risks.
This study has three Specific Aims:
Aim 1: Evaluate MMORE in a randomized controlled study with pregnant women as an adjunct to MOUD treatment as usual care for impact on treatment retention, opioid abstinence, and relapse risks.
Aim 2: Examine mechanisms of effect of MMORE on outcomes.
Aim 3: Evaluate barriers and facilitators to sustainable implementation of MMORE as an adjunct to MOUD for pregnant and parenting women.
This study has three Specific Aims:
Aim 1: Evaluate MMORE in a randomized controlled study with pregnant women as an adjunct to MOUD treatment as usual care for impact on treatment retention, opioid abstinence, and relapse risks.
Aim 2: Examine mechanisms of effect of MMORE on outcomes.
Aim 3: Evaluate barriers and facilitators to sustainable implementation of MMORE as an adjunct to MOUD for pregnant and parenting women.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R33AT010117 | NIH | None | https://reporter.nih.gov/quic… | View |