ACTIVE_NOT_RECRUITING

Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.

Official Title

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

Quick Facts

Study Start:2024-08-06
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06496230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently pregnant and less than 33 weeks gestational age,
  2. * History of OUD within past 3 years,
  3. * Confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD,
  4. * Living in the United States,
  5. * Between 18-45 years of age.
  1. * Carrying multiples (i.e., twins, triplets, etc.);
  2. * High-risk pregnancies including the following conditions: hyperemesis defined as hospitalization for intractable nausea and vomiting, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester;
  3. * Current psychotic symptoms and/or active suicidal intent;
  4. * Experiencing cognitive or emotional impairment that precludes providing informed consent;
  5. * Incarcerated/pending incarceration or institutionalized during the study period.

Contacts and Locations

Principal Investigator

Sara Witcraft
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Sara Witcraft, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-08-06
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • Anxiety
  • Mental Health
  • Pregnancy
  • Psychiatry
  • Sleep Disorders
  • Substance Use
  • Women's Health

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Pregnancy Related