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Buprenorphine for Opioid Addiction during Pregnancy (MOMs Trial)
MOMs Trial Summary
This trial is testing whether an extended-release form of buprenorphine is as effective as the standard form in treating pregnant women with opioid use disorder, with the goal of improving outcomes for mother and child.
MOMs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOMs Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MOMs Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.I am not in, nor planning to join, high-intensity residential addiction treatment that restricts my movement.I plan to give birth in a hospital that follows specific protocols for newborn withdrawal syndrome.I am between 18 and 41 years old.I am pregnant, between 6-30 weeks along, and plan to continue my pregnancy.I am not currently on methadone or naltrexone for opioid use disorder.
- Group 1: BUP-XR
- Group 2: BUP-SL
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research allow for participants that are above a certain age?
"The age parameters for this trial are much narrower than others, as only patients between 18-41 years old can enroll. In contrast, 515 clinical trials allow people under the age of 18 to participate while 1584 extend to those over 65."
Who qualifies to participate in this research?
"This particular clinical trial is testing an experimental medication for treating opioid abuse in adults aged 18-41. They are looking for around 200 participants in total."
Are there any available openings for new participants in this clinical trial?
"Yes, this is an ongoing clinical trial that is currently recruiting patients. According to the listing on clinicaltrials.gov, the trial was posted on July 21st, 2020 and last updated on November 11th, 2020."
How many people can enroll in this research project?
"In order to successfully complete this clinical trial, 200 patients who meet the specified inclusion criteria must be recruited. These potential participants can come from different locations such as Pregnancy Recovery Center at Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania and Gateway Community Services in Jacksonville, Florida."
Could you please summarize the findings of other research projects involving Buprenorphine Injection?
"Right now, there are 60 different ongoing studies evaluating Buprenorphine Injection's efficacy. Out of these, 14 have progressed to Phase 3 testing. Most trials for this medication are being conducted in White River Junction, Vermont; however, there are a total of 243 locations running clinical trials for Buprenorphine Injection around the world."
From how many different sites is this research being monitored?
"The trial is being conducted out of Pregnancy Recovery Center at Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania, Gateway Community Services in Jacksonville, Florida, and Boston Medical Center in Nashville, Tennessee with 8 other locations."
What is Buprenorphine Injection's primary purpose?
"Buprenorphine Injection can ameliorate symptoms associated with opioids, pruritus, pain, and septic shock."
Is Buprenorphine Injection more likely to cause harm than other pain medications?
"There is some evidence from earlier clinical trials that buprenorphine injection is effective and multiple rounds of data supporting its safety, so it received a score of 3."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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