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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
- ClinicalTrials.gov ID
- NCT05790252
- Acronym / sponsor ID
- Patch BRIDGE / 202209093
- Conditions
- Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications, Buprenorphine Withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridge Induction Arm | Experimental | Drug: Buprenorphine Transdermal Matrix Patch |
| Standard Arm | Placebo comparator | Other: Sham patch |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine Transdermal Matrix PatchBuprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours. | Drug | Bridge Induction Arm |
| Sham patchBandage applied at time of induction initiation and removed at 48 hours. | Other | Standard Arm |
Primary outcome
Induction withdrawal severity
Time frame: Days 0 through 4
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+.
3 secondary outcomes
Induction success
Time frame: Days 0 through 7
Treatment adherence
Time frame: Days 0 through delivery
Recovery success
Time frame: Days 0 through delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannie C Kelly, MD, MS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction withdrawal severity (time frame: Days 0 through 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.