Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
NCT ID: NCT06262347
Last Updated: 2025-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2024-06-13
2024-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)
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.
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.
Control
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.
Control
Participants randomized to the control condition will be offered three SAMHSA handouts.
Interventions
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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.
Control
Participants randomized to the control condition will be offered three SAMHSA handouts.
Eligibility Criteria
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Inclusion Criteria
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
1\. have suicidal or homicidal ideation requiring immediate attention.
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Drug Abuse (NIDA)
NIH
T. John Winhusen, PhD
OTHER
Responsible Party
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T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
Principal Investigators
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T. John Winhusen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Gateway Community Services
Jacksonville, Florida, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, United States
Marshall Health MARC Program
Huntington, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2024-0115
Identifier Type: -
Identifier Source: org_study_id
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