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NCT Number: NCT06262347

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Drug Abuse Drug Abuse in Pregnancy Drug Addiction Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Related Substance Use Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gateway Community Services, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Potential participants must be:

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

Exclusion criteria

Potential participants must not:

  • have suicidal or homicidal ideation requiring immediate attention.

Treatment and study plan

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

Behavioral

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

Behavioral

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

Primary outcomes

  1. Medication for Opioid Use Disorder (MOUD) Knowledge Score

    Time frame: 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.

  2. Opioid Overdose Knowledge Score

    Time frame: 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 outcomes

  1. Medication for Opioid Use Disorder (MOUD) Internalized Stigma

    Time frame: 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

  2. Drug Self-efficacy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

T. John Winhusen, PhD

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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)

Acronym: TOME

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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