NCT06262347

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: T. John Winhusen, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Pregnancy Related
• Substance Use
• Drug Abuse
• Drug Abuse in Pregnancy
• Drug Addiction

Interventions

Type	Name	Description
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.
BEHAVIORAL	Control	Participants randomized to the control condition will be offered three SAMHSA handouts.

Timeline

• Start date: 2024-06-13
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2024-02-16
• Last updated: 2025-05-11
• Results posted: 2025-05-11

Locations

6 sites across 1 country: United States