Using a buprenorphine patch to help pregnant women with opioid use disorder
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
This study is testing if a buprenorphine patch can help pregnant women with opioid use disorder manage withdrawal symptoms better than a fake patch before they start their regular treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05790252 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a buprenorphine transdermal patch for the induction of treatment in pregnant patients with opioid use disorder. Participants will use the patch during the withdrawal period before starting sublingual buprenorphine, with daily phone surveys to monitor withdrawal symptoms. The study will compare the patch method to a sham patch to determine which approach results in fewer withdrawal symptoms and higher treatment success rates, as measured by urine drug screens during prenatal appointments.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who meet the diagnostic criteria for opioid use disorder and are seeking treatment.
Not a fit: Patients who are already receiving treatment for opioid use disorder or have a medical contraindication to buprenorphine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for treating opioid use disorder in pregnant women.
How similar studies have performed: While there have been studies on buprenorphine treatment, the use of a transdermal patch for induction in pregnant patients is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Viable pregnancy * Meet diagnostic criteria for opioid use disorder * Receive prenatal care through opioid use disorder specific clinic at our institution * Opioid use within 24 hours prior to presentation * Desire treatment with buprenorphine Exclusion Criteria: * Patients already receiving treatment for opioid use disorder * History of prior induction attempt with buprenorphine * Active withdrawal at time of presentation * Medical contraindication to buprenorphine * Requiring immediate hospitalization
Where this trial is running
St Louis, Missouri
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jeannie C Kelly, MD, MS — Washington University School of Medicine
- Study coordinator: Cassandra J Trammel, MD, MBA
- Email: cjtrammel@wustl.edu
- Phone: 314-121-1129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.