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

NCT06262347 | Completed Results DMC

• 2 other identifiers: 2024-0115UG1DA013732
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

CTN-0150; clinical trials network

Outcome Measures

Primary Outcomes (2)

• 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. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.

  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. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.

  Week 3

Secondary Outcomes (2)

• Medication for Opioid Use Disorder (MOUD) Internalized Stigma

  Week 3

• Drug Self-efficacy

  Week 3

Study Arms (2)

Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

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.

Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential participants must be:
• 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

You may not qualify if:

• Potential participants must not:
• \. have suicidal or homicidal ideation requiring immediate attention.

Sponsors & Collaborators

• T. John Winhusen, PhD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

Gateway Community Services

Jacksonville, Florida, 32204, United States

Location

Pregnancy Recovery Center at Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Utah SUPeRAD Clinic

Salt Lake City, Utah, 84108, United States

Location

Marshall Health MARC Program

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Dosage Forms; Educational Status

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

A significant limitation is that the participant sample was primarily White (89.3%) and non-Latino (92.4%) and, thus, it is unknown whether the results would generalize to a more racially and ethnically diverse population.

Results Point of Contact

• Title: T. John Winhusen, PhD.
• Organization: University of Cincinnati

winhust@ucmail.uc.edu

513-585-8292

Study Officials

• T. John Winhusen, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor; Vice Chair and Division Director of Addiction Sciences

Model Details: This is an intent-to-treat, two-arm, open-label, randomized controlled trial.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: June 13, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (6)