Opioid Use DisorderPhase 3Patch BRIDGENCT05790252
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
A Phase 3 study testing Buprenorphine Transdermal Matrix Patch in people with Opioid Use Disorder and Pregnancy Related, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women only
- Conditions the study is for
- Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk
- What is being tested?
- Buprenorphine Transdermal Matrix Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 31 Aug 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63124
About this study
Official title: Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:
- Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
- Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.
- Conditions
- Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications, Buprenorphine Withdrawal
- Being tested
- Buprenorphine Transdermal Matrix Patch, Sham patch
- Medical subject headings
- Opioid-Related Disorders, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine Transdermal Matrix PatchDrug
Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
Sham patchOther
Bandage applied at time of induction initiation and removed at 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Bridge Induction Arm | Experimental | Not described Receives: Drug: Buprenorphine Transdermal Matrix Patch |
| Standard Arm | Placebo comparator | Not described Receives: Other: Sham patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction withdrawal severity
Subjective Opioid Withdrawal Scale (SOWS) scores collected during buprenorphine induction. SOWS scores range from 0-64 with higher scores representing worse withdrawal. Mild withdrawal is defined as scores 0-10, moderate as 11-20, and severe as 21+.
Measured: Days 0 through 4
Secondary outcomes (3)
Induction success
Induction success, a binary defined by fulling all of the following:
- attendance at 1 week follow up (yes/no)
- buprenorphine in urine at initial follow up (positive/negative on urine drug screening)
- and absence of precipitated withdrawal (yes/no)
Measured: Days 0 through 7
Treatment adherence
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy
Measured: Days 0 through delivery
Recovery success
defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care
Measured: Days 0 through delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start27 Nov 2023
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeannie Kelly, Washington University School of Medicine
- Investigators
- Jeannie C Kelly, MD, MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790252
- Sponsor's protocol ID
- 202209093
- Acronym
- Patch BRIDGE
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No