Buprenorphine Patch for Opioid Addiction in Pregnancy

(Patch BRIDGE Trial)

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

Trial Summary

What is the purpose of this 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: 1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder? 2. 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.

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.

What data supports the effectiveness of the drug Buprenorphine Transdermal Matrix Patch for opioid addiction in pregnancy?

Buprenorphine patches have been shown to be effective in managing chronic pain, providing consistent pain relief and being well-tolerated over long periods. While these studies focus on pain management, the drug's ability to deliver consistent doses and its safety profile suggest potential benefits for managing opioid addiction in pregnancy. ^{1 2 3 4 5}

Is the Buprenorphine Patch safe for use in humans, including during pregnancy?

There is no specific safety data available for the Buprenorphine Patch in pregnancy from the provided research articles. However, pregnancy registries are often used to monitor drug safety during pregnancy, suggesting that such data might exist elsewhere for Buprenorphine or similar medications. ^{6 7 8 9 10}

How is the buprenorphine patch unique for treating opioid addiction in pregnancy?

The buprenorphine patch is unique because it provides a continuous, steady release of medication through the skin, which can help maintain stable drug levels and reduce withdrawal symptoms without the need for frequent dosing. This transdermal (through the skin) delivery system is convenient and may be better tolerated than other forms of buprenorphine, making it a potentially safer option during pregnancy. ^{1 2 3 4 5}

Research Team

Jeannie C Kelly, MD, MS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

Opioid use within 24 hours prior to presentation

I want to be treated with buprenorphine.

Viable pregnancy

Exclusion Criteria

I cannot take buprenorphine due to health reasons.

Patients already receiving treatment for opioid use disorder

I need to be hospitalized right away.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England 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. [2013]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

[Transdermal buprenorphine during pregnancy]. [2018]

4. New Zealand 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. [2022]

5. United States 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. [2013]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Non-compliance with pregnancy prevention recommendations for isotretinoin in Korea between 2019-2020. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Pregnancy Registry program at Glaxo Wellcome Company. [2019]

8. New Zealand 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The antiretrovirals in pregnancy registry: a fifteenth anniversary celebration. [2013]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program. [2018]