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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, and 3-months postpartum

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,543,337 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

831 Previous Clinical Trials

668,929 Total Patients Enrolled

Trustees of Dartmouth CollegeOTHER

23 Previous Clinical Trials

10,681 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants taking part in this medical experiment?

"Yes, the details posted on clinicaltrials.gov confirm that this medical experiment is in need of participants. It was first released to the public on May 1st 2022 and has since been revised a few times; its most recent update occured October 3rd, 20202. To fulfil their research needs, they are searching for 120 volunteers at just one particular site."

Answered by AI

Is this trial still seeking participants?

"Affirmative. Clinicaltrials.gov's information indicates that this experiment is currently looking for participants, having been posted on May 1st 2022 and updated as recently as October 3rd 2022. The research requires 120 volunteers at a single clinical site."

Answered by AI

What are the primary goals of this experiment?

"The primary goal of this study, tracked from baseline to 3-months postpartum, is measuring the Change in opioid abstinence as determined by weekly point of care urine toxicology screening. Supplementary objectives are assessing the Change in stress with the Perceived Stress Scale (PSS), tracking substance use with WHO's Alcohol, Smoking and Substance Involvement Screening Test V3.0 (ASSIST) plus evaluating Opioid addiction severity through 11 DSM-V criteria and gauging anxiety levels via Generalized Anxiety Disorder Scale (GAD)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindful Moms in Recovery

Sarah E. Lord 2022. "Mindful Moms in Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584502.