Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
Key facts
- Who runs it
- T. John Winhusen, PhD
- Where
- Charleston, Huntington, Jacksonville, Nashville, Pittsburgh, and Salt Lake City, United StatesSee the 6 sites
- Trial code
- Status
- Completed
- People taking part
- 131 people enrolled
- Started
- 13 Jun 2024
- Ended
- 11 Nov 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)
- Control
- Record updated
- 11 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Potential participants must not:
- have suicidal or homicidal ideation requiring immediate attention
Where in United States
- Medical University of South CarolinaCharleston, United States
- Marshall Health MARC ProgramHuntington, United States
- Gateway Community ServicesJacksonville, United States
- Vanderbilt University Medical CenterNashville, United States
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMCPittsburgh, United States
- University of Utah SUPeRAD ClinicSalt Lake City, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)Treatment being tested
Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) TOME entails a trained RA: 1) administering a REDCap survey to assess an individual's opioid-overdose/MOUD knowledge; and 2) reviewing the personal feedback reports with the recipient.
- ControlExisting treatment, for comparison
Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: SAMHSA handouts SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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)
- Record updated
- 11 May 2025