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

Pregnancy Related Clinical Trial

— TOME  

Official title:

NIDA CTN Protocol 0150: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD: A Pilot Randomized Trial (TOME Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262347
• Other study ID #: 2024-0115
• Secondary ID: UG1DA013732
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: June 20, 2025

Study information

• Verified date: June 2024
• Source: University of Cincinnati
• Contact: Frankie Kropp, MS
• Phone: 513-585-8290
• Email: kroppfb[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Abuse
• Drug Abuse in Pregnancy
• Drug Addiction
• Opiate Overdose
• Opioid Use Disorder
• Opioid-Related Disorders
• Pregnancy Related
• Substance Use
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Marshall Health MARC Program	Huntington	West Virginia
United States	Gateway Community Services	Jacksonville	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Pregnancy Recovery Center at Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	University of Utah SUPeRAD Clinic	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
T. John Winhusen, PhD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication for Opioid Use Disorder (MOUD) knowledge score	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	Screening through Week 3
Primary	Opioid Overdose knowledge score	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	Screening through Week 3
Secondary	Medication for Opioid Use Disorder (MOUD) Internalized Stigma	This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire.; Score range: 25 - 125 - higher score indicates greater MOUD stigma	Screening through Week 3
Secondary	Drug Self-efficacy	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	Screening through Week 3