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Telemedicine vs Group Care for Opioid Use Disorder During Pregnancy (PATH Trial)

N/A

Waitlist Available

Led By Wendy Hansen, MD

Research Sponsored by Wendy F Hansen

Eligibility Criteria Checklist

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

Must have

Receiving Medication Assisted Therapy (buprenorphine products or methadone)

Pregnant women at 6 to 32 weeks' gestational age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two methods of delivering care to rural areas for perinatal opioid use disorder - local group support vs. UK nurse/counselor telemedicine.

Who is the study for?

This trial is for pregnant women between 6 to 32 weeks' gestation in Central and Eastern Kentucky who are on Medication Assisted Therapy (like buprenorphine or methadone) due to a history of Opioid Use Disorder. They must be getting prenatal care at one of the eleven study sites.

What is being tested?

The PATH Home Trial compares two ways of delivering the UK-PATHways program for perinatal opioid use disorder: local group support versus telemedicine with UK nurses/counselors, aiming to improve outcomes for mothers and infants in rural areas.

What are the potential side effects?

Since this trial focuses on service delivery methods rather than medications, traditional side effects aren't applicable. However, participants may experience differences in satisfaction or effectiveness between the two approaches.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am currently on medication-assisted therapy for addiction.

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I am pregnant and between 6 to 32 weeks along.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of medication requiring neonatal abstinence syndrome (NAS)

Secondary study objectives

Adherence to a pediatric visit schedule

Vaccines

Change in cigarette dependency

+14 more

Other study objectives

Acceptance of long-term contraception

Change in employment status

Change in household size

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: Telemedicine EducationExperimental Treatment1 Intervention

This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff.

Group II: Group Care EducationActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telemedicine

2008

Completed Phase 4

~3540

0 / 2Eligibility criteria met