NCT04824521

Brief Summary

Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 16, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

March 8, 2021

Results QC Date

September 18, 2023

Last Update Submit

January 12, 2024

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • Client Satisfaction

    Participants will complete the Client Satisfaction Questionnaire.

    8 weeks

Secondary Outcomes (1)

  • SUD Symptoms - Mini Neuropsychiatric Interview

    8 weeks

Study Arms (1)

Mindfulness-Oriented Recovery Enhancement via tele-health

EXPERIMENTAL

Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.

Behavioral: Mindfulness-Oriented Recovery Enhancement

Interventions

Mindfulness-Oriented Recovery EnhancementBEHAVIORAL

MORE is a mindfulness-based intervention.

Mindfulness-Oriented Recovery Enhancement via tele-health

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be pregnant.
  • Must be able to communicate in English.
  • Must have met criteria for opioid use disorder in the past year.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Montana

Missoula, Montana, 59802, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

Unable to recruit the number of participants anticipated possibly due to stigma related to substance use in pregnancy, as well as challenges related to Covid-19 and the impact of the pandemic on healthcare and social service systems.

Results Point of Contact

Title
Dr. Sarah Reese
Organization
University of Montana
Sarah.reese@mso.umt.edu
7313940288

Study Officials

  • Sarah Reese

    University of Montana

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Social work

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 1, 2021

Study Start

October 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

January 16, 2024

Results First Posted

January 16, 2024

Record last verified: 2024-01

Locations

US(1)