Technology-Enhanced Therapy for Opioid Use Disorder During Pregnancy

Overseen By Morgan Thomas

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Buprenorphine

Disqualifiers: Multiples, High-risk pregnancies, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 months

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a technology-enhanced therapy for pregnant individuals treated for opioid use disorder (OUD) with buprenorphine. Researchers aim to determine if this therapy, which includes counseling sessions and a mobile app, is more effective than monitoring medication use alone. Participants may attend therapy sessions or track their medication. This trial suits pregnant individuals in the U.S. with OUD who are prescribed buprenorphine. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance treatment options for pregnant individuals with OUD.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it does require that you have a confirmed prescription for buprenorphine to treat opioid use disorder.

What prior data suggests that this technology-enhanced therapy is safe for pregnant individuals with opioid use disorder?

Research has shown that untreated opioid use disorder (OUD) during pregnancy can harm both the pregnant person and the baby, highlighting the importance of effective treatment. The EMPWR program under study combines a short therapy session called cognitive-behavioral therapy (CBT) with a mobile app to assist pregnant individuals taking medications like buprenorphine for OUD.

While detailed safety data on the EMPWR program itself is limited, its components have been evaluated. CBT is generally safe and has been successfully used in various contexts. The mobile app serves as a support tool for therapy and does not involve any new medication.

The study uses buprenorphine, which the FDA has already approved for treating OUD, including during pregnancy. This approval indicates its safety and effectiveness for this purpose.

In summary, although specific safety data for EMPWR is limited, existing research and approvals suggest the program's components are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPWR treatment for opioid use disorder during pregnancy because it combines a brief cognitive-behavioral intervention with a mobile app, offering a tech-savvy approach to support pregnant individuals. Unlike standard treatments that typically rely solely on medication monitoring, EMPWR provides an additional layer of psychological support and empowerment through digital means. This integrated approach is thought to enhance adherence and engagement, potentially leading to better outcomes for both the mother and the baby.

What evidence suggests that this technology-enhanced therapy is effective for opioid use disorder during pregnancy?

Research has shown that untreated opioid use disorder (OUD) during pregnancy can harm both the pregnant person and the baby. Studies have found that medications like buprenorphine effectively manage OUD during pregnancy. In this trial, the EMPWR program combines cognitive-behavioral therapy with a mobile app to support pregnant individuals. This approach aims to improve outcomes by providing additional mental health support and monitoring. Early results suggest that integrated care programs help individuals stay on treatment and reduce substance use, leading to better health for both mother and baby. ^{3 6 7 8 9}

Who Is on the Research Team?

Sara Witcraft

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for pregnant individuals aged 18-45 in the U.S., between 13 and nearly 33 weeks of gestation, with current or recent opioid use disorder (OUD) within the past three years. They must have a prescription for buprenorphine to treat OUD, which can be from before or during pregnancy.

Inclusion Criteria

Living in the United States

I am pregnant and between 13 to 32 weeks along.

Current OUD or history of OUD within the past 3 years

Exclusion Criteria

Incarcerated/pending incarceration or institutionalized during the study period

I do not speak English.

Carrying multiples

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either technology-enhanced therapy or medication monitoring. Therapy includes four 60-minute sessions during pregnancy, an additional 30-minute session towards the end of pregnancy, and 6 monthly postpartum sessions. Medication monitoring involves logging medication intake for two months.

8-12 months

Follow-up

Participants are monitored for retention and engagement through 3-month and 6-month postpartum follow-up assessments.

6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)

Trial Overview The study compares technology-enhanced therapy (EMPWR), including mobile app support and multiple therapy sessions during and after pregnancy, against standard medication monitoring where participants log their buprenorphine intake. Participants are randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: EMPWR Experimental Treatment 1 Intervention

Brief cognitive-behavioral intervention and mobile application

Group II: Control Active Control 1 Intervention

medication monitoring

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6881108/

Opioid use disorder in pregnancy - PMC - PubMed Central Data and experience have shown that untreated OUD during pregnancy negatively impacts the pregnant person, fetus, and subsequent child.

2. cdc.gov cdc.gov/mmwr/volumes/72/ss/ss7203a1.htm

Medication for Opioid Use Disorder During Pregnancy Among the 5,541 reported pregnancies at the seven clinical sites, 4,381 (79.1%) included persons who received MOUD (i.e., receipt of ...

3. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003119

Medications for opioid use disorder among pregnant women ... We sought to examine trends in medications for OUD among pregnant women referred to treatment by criminal justice agencies and other sources before and after ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923000802

Collaborative care programs for pregnant and postpartum ... A randomized clinical trial of extended release compared to sublingual buprenorphine among pregnant and postpartum individuals (PPI)

5. ncsacw.acf.gov ncsacw.acf.gov/files/Collaborative_Approach_508.pdf

A Collaborative Approach to the Treatment of Pregnant ... A Collaborative Approach to the. Treatment of Pregnant Women with Opioid Use Disorders. HHS Publication No. (SMA) 16-4978. Rockville, MD: Substance Abuse and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10154076/

Medication for Opioid Use Disorder During Pregnancy From 1999 to 2014, the prevalence of opioid use disorder (OUD) among pregnant women in the United States quadrupled from 1.5 to 6.5 per 1,000 ...

7. aspe.hhs.gov aspe.hhs.gov/reports/opioid-use-treatment-pregnant-postpartum-women-children

Opioid Use Treatment of Pregnant/Postpartum Women and ... While the majority of pregnant women in this analysis access OUD treatment during pregnancy (69%), only 45% of them used MOUD prenatally, and 31 ...

8. end-overdose-epidemic.org end-overdose-epidemic.org/wp-content/uploads/2024/02/AMA-Manatt-2024-Improving-Access-to-Care-Pregnant-Parenting-People-with-SUD.pdf

Improving Access to Care for Pregnant and Postpartum ... Use During Pregnancy With Risk of Nonfatal Drug Overdose Among Pregnant Persons With Opioid Use · Disorder in the US. Journal of the American ...

9. stacks.cdc.gov stacks.cdc.gov/view/cdc/120105

Impact of prenatal substance use policies on commercially ... Our findings suggest that supportive approaches that enhance access to SUD treatment may effectively reduce adverse maternal outcomes associated with prenatal ...