CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06262347
NCT06262347N/ACompleted
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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)

T. John Winhusen, PhD·interventional·Posted Feb 16, 2024·Updated May 11, 2025

In Brief

A clinical study evaluating Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) and Control for Opioid Use Disorder and 5 related conditions. Completed, enrolled 131 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder, Pregnancy Related, Substance Use, Drug Abuse, Drug Abuse in Pregnancy, Drug Addiction
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
20252026
First PostedFeb 16, 2024
Enrollment StartJun 13, 2024
Primary CompletionNov 11, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.4 years ago

Interventions

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.

Controlbehavioral

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