Clinical trial NCT06262347: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Pregnancy Related
Substance Use
Drug Abuse
Drug Abuse in Pregnancy
Drug Addiction
Keywords: CTN-0150
clinical trials network
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-16
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an intent-to-treat, two-arm, open-label, randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication for Opioid Use Disorder (MOUD) Knowledge Score
timeFrame: Week 3
measure: Opioid Overdose Knowledge Score
timeFrame: Week 3
Secondary outcomes:
measure: Medication for Opioid Use Disorder (MOUD) Internalized Stigma
timeFrame: Week 3
measure: Drug Self-efficacy
timeFrame: Week 3
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Pittsburgh
country: United States
facility: Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah SUPeRAD Clinic
state: Utah
city: Huntington
country: United States
facility: Marshall Health MARC Program
state: West Virginia
Study officials:
affiliation: University of Cincinnati
name: T. John Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References: