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

Not Applicable

Completed

• Conditions: Pregnancy Related; Drug Abuse; Opioid Use Disorder; Drug Addiction; Drug Abuse in Pregnancy; Substance Use
• Interventions: Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME); Behavioral: Control

• Registration Number: NCT06262347
• Lead Sponsor: T. John Winhusen, PhD

Brief 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.

Detailed Description

This is an intent-to-treat, two-arm, open-label, randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TOME or Control, balancing on site. Participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Study Start: 2024-06-13
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Status Verified: 2025-04
• Results First Submitted: 2025-04-03
• Results First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Results First Posted: 2025-05-11
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

Potential participants must be:

1. 18 years of age or older;
2. Pregnant or be within 12 months postpartum;
3. Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed;
4. Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria

Potential participants must not:

1. have suicidal or homicidal ideation requiring immediate attention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)	Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)	Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) TOME entails a trained RA: 1) administering a REDCap survey to assess an individual's opioid-overdose/MOUD knowledge; and 2) reviewing the personal feedback reports with the recipient.
Control	Control	Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: SAMHSA handouts SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.

Primary Outcome Measures

Name	Time	Method
Medication for Opioid Use Disorder (MOUD) Knowledge Score	Week 3	This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Opioid Overdose Knowledge Score	Week 3	This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS).; Opioid-overdose knowledge, potential score of 0-31; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.

Secondary Outcome Measures

Name	Time	Method
Medication for Opioid Use Disorder (MOUD) Internalized Stigma	Week 3	This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire.; Score range: 1 - 5; higher score indicates greater MOUD stigma
Drug Self-efficacy	Week 3	This will be assessed with the Thoughts about abstinence (TAA) instrument.; Drug Self-efficacy Score range: 0 - 9; higher score indicates greater expected success in avoiding drug use

Trial Locations

Locations (6)

Gateway Community Services; 🇺🇸 Jacksonville, Florida, United States

Pregnancy Recovery Center at Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Utah SUPeRAD Clinic; 🇺🇸 Salt Lake City, Utah, United States

Marshall Health MARC Program; 🇺🇸 Huntington, West Virginia, United States