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Behavioral Intervention

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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication for Opioid Use Disorder (MOUD) knowledge score
Opioid Overdose knowledge score
Secondary outcome measures
Drug Self-efficacy
Medication for Opioid Use Disorder (MOUD) Internalized Stigma

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.

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Who is running the clinical trial?

T. John Winhusen, PhDLead Sponsor
3 Previous Clinical Trials
437 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,714 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,256 Total Patients Enrolled
~60 spots leftby Dec 2024
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