Tailored Education for Opioid Use Disorder During Pregnancy (TOME Trial)

N/A

Recruiting

Research Sponsored by T. John Winhusen, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening through week 3

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using TOME can help pregnant and postpartum individuals increase their knowledge about Medication for Opioid Use Disorder (MOUD) and opioid-overdose."

Who is the study for?

This trial is for pregnant or postpartum individuals within 12 months after giving birth, who are at least 18 years old and currently enrolled in a medication program for opioid use disorder. They must understand English to give informed consent.

What is being tested?

The study tests if personalized education can boost knowledge about opioid overdose and treatment options among pregnant/postpartum persons on opioid addiction medications like buprenorphine or methadone.

What are the potential side effects?

Since the intervention involves education rather than medication, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening through week 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening through week 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through week 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication for Opioid Use Disorder (MOUD) knowledge score

Opioid Overdose knowledge score

Secondary study objectives

Drug Self-efficacy

Medication for Opioid Use Disorder (MOUD) Internalized Stigma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)Experimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.

0 / 1Eligibility criteria met