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

NACompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

June 13, 2024

Primary Completion Date

November 11, 2024

Study Completion Date

November 11, 2024

Conditions
Opioid Use DisorderPregnancy RelatedSubstance UseDrug AbuseDrug Abuse in PregnancyDrug Addiction
Interventions
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.

BEHAVIORAL

Control

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

Trial Locations (6)

15213

Pregnancy Recovery Center at Magee-Womens Hospital of UPMC, Pittsburgh

25701

Marshall Health MARC Program, Huntington

29425

Medical University of South Carolina, Charleston

32204

Gateway Community Services, Jacksonville

37232

Vanderbilt University Medical Center, Nashville

84108

University of Utah SUPeRAD Clinic, Salt Lake City

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

T. John Winhusen, PhD

OTHER

NCT06262347 - Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD | Biotech Hunter | Biotech Hunter