MedTrace Logo

Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD

NCT06262347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-05-11

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.

Conditions

  • Opioid Use Disorder
  • Pregnancy Related
  • Substance Use
  • Drug Abuse
  • Drug Abuse in Pregnancy
  • Drug Addiction

Interventions

BEHAVIORAL

Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)

The TOME intervention is a modified version of the personally-tailored opioid overdose prevention education and naloxone distribution (PTOEND) intervention (Winhusen et al. Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. Drug Alcohol Depend. Nov 1 2020;216:108265). Modifications include updating the knowledge assessment/education to reflect changes in the drug supply (i.e., the current high prevalence of fentanyl and increasing prevalence of xylazine) and the addition of items specific to pregnancy. Like PTOEND, TOME is a computer-guided intervention which utilizes REDCap to complete assessments and automatically generate personally-tailored feedback reports.

BEHAVIORAL

Control

Participants randomized to the control condition will be offered three SAMHSA handouts.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • T. John Winhusen, PhD

    lead OTHER

Principal Investigators

  • T. John Winhusen, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2024-11-11
Completion
2024-11-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06262347 on ClinicalTrials.gov