N/A
N=131
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
Opioid Use Disorder · Pregnancy Related · Substance Use · Drug Abuse · Drug Abuse in Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT06262347 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Medication for Opioid Use Disorder (MOUD) Knowledge Score — 83.5; 72.0 percentage of correct answers
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- T. John Winhusen, PhD
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication for Opioid Use Disorder (MOUD) Knowledge Score |
83.5; 72.0 | — |
| PRIMARY Opioid Overdose Knowledge Score |
90.1; 82.6 | — |
| SECONDARY Medication for Opioid Use Disorder (MOUD) Internalized Stigma |
1.5; 1.6 | — |
| SECONDARY Drug Self-efficacy |
2.3; 1.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06262347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.