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

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)

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 Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Substance Use; Opioid Use Disorder; Drug Abuse; Drug Addiction; Drug Abuse in Pregnancy
• Intervention / Treatment: Behavioral: Control; Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frankie Kropp, MS; Phone Number: 513-585-8290; Email: kroppfb@ucmail.uc.edu
• Study Contact Backup: Name: Ben Kropp, MSLS; Phone Number: 513-585-8287; Email: kroppbn@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Control; Participants randomized to the control condition will be offered three SAMHSA handouts.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication for Opioid Use Disorder (MOUD) knowledge score	This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10 - higher score indicates more knowledge	Screening through Week 3
Opioid Overdose knowledge score	This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS). Opioid-overdose knowledge, potential score of 0-31 - higher score indicates more knowledge	Screening through Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication for Opioid Use Disorder (MOUD) Internalized Stigma	This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire. Score range: 25 - 125 - higher score indicates greater MOUD stigma	Screening through Week 3
Drug Self-efficacy	This will be assessed with the Thoughts about abstinence (TAA) instrument. Drug Self-efficacy Score range: 0 - 9 - higher score indicates greater expected success in avoiding drug use	Screening through Week 3

Collaborators and Investigators

• Sponsor: T. John Winhusen, PhD
• Collaborators: National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: T. John Winhusen, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: clinical trials network; CTN-0150
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Drug Overdose; Substance-Related Disorders; Opioid-Related Disorders; Opiate Overdose; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2024-0115; UG1DA013732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No