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

Recruiting
18 years of age
Female
Phase N/A

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Overview

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.

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.

Study details

Opioid Use Disorder, Pregnancy Related, Substance Use, Drug Abuse, Drug Abuse in Pregnancy

NCT06262347

T. John Winhusen, PhD

22 June 2024

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