Buprenorphine Patch for Opioid Addiction in Pregnancy

(Patch BRIDGE Trial)

Recruiting at 1 trial location

Overseen By Cassandra J Trammel, MD, MBA

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Disqualifiers: Current treatment, Prior induction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: From induction to delivery

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a buprenorphine patch, a medication for opioid addiction, can help pregnant patients begin treatment more comfortably. The researchers aim to determine if the patch reduces withdrawal symptoms and increases treatment success compared to the usual method of withdrawal before starting oral medication. Participants will wear the patch during withdrawal and be monitored on their ability to manage without opioids. This trial suits pregnant patients who have used opioids in the last 24 hours and wish to start buprenorphine treatment while receiving prenatal care at a specialized clinic. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you are not already receiving treatment for opioid use disorder.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using buprenorphine as a patch is generally safe and effective for treating opioid addiction. Studies have found that it reduces cravings and improves the quality of life for those dealing with addiction. However, buprenorphine patches can be addictive, especially with long-term use.

For pregnant women, buprenorphine might cause neonatal opioid withdrawal syndrome in newborns, leading to withdrawal symptoms after birth. Despite this risk, buprenorphine is often used during pregnancy because it helps manage opioid addiction, which is crucial for the health of both the mother and baby.

These findings suggest that the buprenorphine patch can be a safe option for many, with special considerations for pregnant women. Always follow a doctor's advice when using this medication. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Buprenorphine Transdermal Matrix Patch for opioid addiction in pregnancy because it offers a new delivery method that could be more convenient and effective. Unlike standard treatments like oral buprenorphine or methadone, this patch provides a continuous release of medication through the skin, potentially leading to more stable blood levels and fewer withdrawal symptoms. This method may improve adherence and outcomes for pregnant individuals by ensuring consistent medication levels without the need for daily dosing.

What evidence suggests that the buprenorphine patch is effective for opioid addiction in pregnancy?

Research has shown that the buprenorphine skin patch, which participants in this trial may receive, can effectively treat opioid addiction. One study found that, compared to methadone, buprenorphine was linked to a lower risk of early birth and higher birth weight in pregnant patients. The patch slowly releases the medication into the bloodstream, potentially easing withdrawal symptoms. This approach offers a possible alternative for pregnant patients, aiding their transition into further treatment. While the patch can be habit-forming, using it as directed by a doctor is important. ^{2 3 6 7 8}

Who Is on the Research Team?

Jeannie C Kelly, MD, MS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who have opioid use disorder and want to start buprenorphine treatment. They must have used opioids within the last 24 hours, be receiving prenatal care at a specific clinic, and not have tried buprenorphine induction before or need immediate hospitalization.

Inclusion Criteria

Viable pregnancy

Meet diagnostic criteria for opioid use disorder

Opioid use within 24 hours prior to presentation

Exclusion Criteria

Patients already receiving treatment for opioid use disorder

Active withdrawal at time of presentation

I cannot take buprenorphine due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive a buprenorphine patch during the required withdrawal period before starting sublingual treatment. They are surveyed daily by phone to assess withdrawal symptoms.

1 week

Daily phone surveys

Treatment

Participants are followed at prenatal appointments to evaluate treatment success based on urine drug screen results.

From induction to delivery

Regular prenatal appointments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine Transdermal Matrix Patch
• Sham patch

Trial Overview The study tests if a buprenorphine patch can help manage withdrawal symptoms better than no patch during the period before starting sublingual buprenorphine. Success of the treatment will be monitored through daily phone surveys and urine drug screens at prenatal visits.

How Is the Trial Designed?

Group I: Bridge Induction Arm Experimental Treatment 1 Intervention

Group II: Standard Arm Placebo Group 1 Intervention

Buprenorphine Transdermal Matrix Patch is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Butrans for:

• Severe pain
• Chronic pain
• Opioid use disorder

Approved in European Union as BuTrans for:

• Severe pain
• Chronic pain
• Opioid dependence

Approved in Canada as Transtec for:

• Severe pain
• Chronic pain

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Transdermal buprenorphine patches are effective for managing moderate-to-severe cancer pain and severe pain unresponsive to nonopioid analgesics, with 90% of patients rating their pain relief as satisfactory over an average treatment duration of 7.5 months.

The patches were well tolerated, with a high user-friendliness rating of 94.6%, and most adverse events were mild and temporary, indicating a favorable safety profile compared to traditional opioid treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal buprenorphine in the treatment of chronic pain. Sittl, R.[2022]

After the introduction of a risk management program (RMP) in Korea, the average duration of isotretinoin prescriptions significantly decreased from 68.8 days to 28.0 days, indicating a reduction in potential exposure time.

Despite the RMP, the proportion of patients exposed to isotretinoin during the study period remained low at 1.43%, suggesting that compliance with the program did not significantly improve, highlighting the need for further long-term evaluations of the RMP's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-compliance with pregnancy prevention recommendations for isotretinoin in Korea between 2019-2020. Choi, EJ., Han, JY.[2021]

The Antiretrovirals in Pregnancy Registry (APR) has successfully monitored the safety of antiretroviral drugs in pregnant women for 15 years, helping to identify any potential increase in birth defects associated with these medications.

This multinational and multi-company collaborative effort has provided valuable insights into drug safety risk management, demonstrating the importance of registries in protecting maternal and fetal health during the HIV pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antiretrovirals in pregnancy registry: a fifteenth anniversary celebration. Tilson, HH., Doi, PA., Covington, DL., et al.[2013]

The 7-day buprenorphine transdermal patch has been shown to be effective in managing chronic non-malignant pain, demonstrating analgesic efficacy comparable to sublingual buprenorphine and noninferior to other common pain medications like tramadol and codeine plus paracetamol.

This transdermal formulation is generally well-tolerated, with a ceiling effect for respiratory depression, making it a safer option for patients, especially the elderly or those with renal issues, as it requires no dosage adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine 5, 10 and 20 μg/h transdermal patch: a review of its use in the management of chronic non-malignant pain. Plosker, GL.[2022]

A study involving 49 patients with chronic pain found that extending the wear time of buprenorphine transdermal patches from 3 days to 4 days did not significantly affect pain relief or patient satisfaction, indicating that both durations are effective for managing pain.

Skin tolerability and the safety profile were comparable between the two regimens, with similar rates of adverse events, suggesting that extending patch wear time may be a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal buprenorphine patches applied in a 4-day regimen versus a 3-day regimen: a single-site, Phase III, randomized, open-label, crossover comparison. Likar, R., Lorenz, V., Korak-Leiter, M., et al.[2013]

Isotretinoin is a highly effective medication for certain skin conditions but poses significant risks as a teratogen, particularly for women of reproductive age, necessitating careful risk management to prevent exposure during pregnancy.

The introduction of generic isotretinoin has complicated risk management efforts, highlighting the need for a unified registration system among manufacturers to better track and minimize the risk of isotretinoin-exposed pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we ensure the safe use of known human teratogens? Introduction of generic isotretinoin in the US as an example. Honein, MA., Moore, CA., Erickson, JD.[2018]

A case study of a pregnant woman using a lower dose transdermal buprenorphine patch (21 microg/h) for over 2 years showed no complications for her or her child, indicating its potential safety during pregnancy.

The patient experienced continuous excellent pain relief with the buprenorphine patch, which was well tolerated and did not affect her vigilance, highlighting its efficacy as a pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transdermal buprenorphine during pregnancy]. Ebner, E., Wiedmann, M.[2018]

In a study involving 4030 patients with chronic pain, the buprenorphine transdermal patch significantly reduced pain intensity by 73.5% over 3 months, with most patients reporting 'very good' or 'good' pain relief.

The patch was well-tolerated, with only 0.8% of patients experiencing non-serious adverse reactions, and 70.1% of patients planned to continue treatment, indicating its effectiveness and ease of use in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal buprenorphine for the treatment of moderate to severe chronic pain: results from a large multicenter, non-interventional post-marketing study in Poland. Przeklasa-Muszynska, A., Dobrogowski, J.[2013]

Glaxo Wellcome has established five international pregnancy registries to monitor the potential teratogenic effects of medications like Acyclovir, Lamotrigine, and Bupropion during pregnancy, aiming to enhance safety information for these drugs.

While these registries provide valuable data on medication use in pregnancy, their effectiveness can be limited by sample size and representativeness, highlighting the need for careful interpretation of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pregnancy Registry program at Glaxo Wellcome Company. White, AD., Andrews, EB.[2019]

The Merck Pregnancy Registry Program collects and analyzes data on drug exposures during pregnancy to better understand the safety profiles of Merck products, helping women and healthcare providers make informed decisions about treatment during pregnancy.

Despite limitations like small sample sizes and potential biases in voluntary reporting, the registry effectively gathers early pregnancy outcome reports, allowing for systematic review of drug effects on pregnancies and identification of unusual birth defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program. Shields, KE., Wiholm, BE., Hostelley, LS., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG ... The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201818310761

Transdermal buprenorphine patch: Potential for role in ... The present review suggests that transdermal buprenorphine can be an effective treatment alternative in patients with opioid dependence, being planned for ...

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

Medication for Opioid Use Disorder During Pregnancy Results: The MAT-LINK surveillance network gathered data on 5,541 reported pregnancies with a known pregnancy outcome during 2014–2021 among ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5129590/

Buprenorphine compared with methadone to treat pregnant ... Conclusions. Moderately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment ...

5. medlineplus.gov medlineplus.gov/druginfo/meds/a613042.html

Buprenorphine Transdermal Patch Buprenorphine patches can be habit forming, especially with prolonged use. Use buprenorphine patches exactly as directed.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459126/

Buprenorphine - StatPearls - NCBI Bookshelf The drug proves to be an effective choice for addressing opioid dependence by diminishing cravings and enhancing the overall quality of life during addiction ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf

BUTRANS label - accessdata.fda.gov Neonatal Opioid Withdrawal Syndrome. Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life ...

8. library.samhsa.gov library.samhsa.gov/sites/default/files/sma18-5054.pdf

Treating Pregnant and Parenting Women with Opioid Use ... Buprenorphine + naloxone in the treatment of opioid dependence during pregnancy: Initial patient care and outcome data. American Journal on Addictions,. 22(3) ...