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Intervention as adjunct to Treatment as Usual for Opioid Use Disorder (MMORE Trial)

N/A
Waitlist Available
Led By Sarah E Lord
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, and 3-months postpartum
Awards & highlights

MMORE Trial Summary

This trialtests if yoga & mindfulness can help pregnant & parenting women with OUD during perinatal services & medication treatment.

Eligible Conditions
  • Opioid Use Disorder

MMORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, and 3-months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, and 3-months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in opioid abstinence from baseline as assessed by number of weeks consistently abstinent from opioids as determined by weekly point of care urine toxicology screening conducted as part of treatment as usual.
Retention in medication treatment for opioid use disorder as assessed by number of weeks buprenorphine or methadone present in urine toxicology screening in clinical record conducted as part of treatment as usual.
Secondary outcome measures
Change in anxiety from baseline, as assessed with the Generalized Anxiety Disorder Scale (GAD)
Change in depression from baseline, as assessed with the Edinburgh Prenatal and Postnatal Depression Scale.
Change in mindfulness from baseline, as assessed with the Mindful Attention Awareness Scale (MAAS)
+3 more
Other outcome measures
Change from baseline in quality of life measured by the World Health Organization (WHO) Quality of Life Brief.
Change in pain perception from baseline, as measured by the visual analog scale (VAS)

MMORE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention as adjunct to Treatment as UsualExperimental Treatment1 Intervention
Participants will attend via Zoom an 8-session group-based yoga-mindfulness intervention offered over the course of approximately 10 consecutive weeks. Participants will also be asked to use a mobile companion app once a week during the intervention period. All intervention participants also receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
Group II: Treatment as UsualActive Control1 Intervention
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Moms Yoga Mindfulness Intervention
2022
N/A
~10

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
528 Previous Clinical Trials
2,541,372 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,739 Total Patients Enrolled
Trustees of Dartmouth CollegeOTHER
24 Previous Clinical Trials
10,741 Total Patients Enrolled

Media Library

Mindful Moms Yoga Mindfulness Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04584502 — N/A
Opioid Use Disorder Research Study Groups: Intervention as adjunct to Treatment as Usual, Treatment as Usual
Opioid Use Disorder Clinical Trial 2023: Mindful Moms Yoga Mindfulness Intervention Highlights & Side Effects. Trial Name: NCT04584502 — N/A
Mindful Moms Yoga Mindfulness Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04584502 — N/A
~1 spots leftby Jun 2025
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