MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
A legfontosabb adatok
- Ki végzi
- Boston Medical Center
- Hol
- Boston és Carrboro (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 46 fő vett részt
- Kezdés
- 2018. dec. 1.
- Befejezés
- 2024. máj. 8.
- A vizsgálat típusa
- Megfigyeléses, 3 csoport
- A vizsgált kezelések
- Pharmacokinetic analysis
- Safety and Efficacy
- Genetic and epigenetic analysis
- Breast milk analysis
- A regiszteradat frissítve
- 2024. november 4.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
- Plan to deliver infant at BMC or UNC
- Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
- English speaking
- Singleton pregnancy
Ki nem vehet részt
- OUD on prescribed methadone, or no maintenance medication
- Severe psychiatric illness or cognitively impairing ability to provide informed consent
- OUD on Subutex formulation of buprenorphine
- Current maternal incarceration
- Women who present for care >31 0/7 weeks
- Multiple gestation pregnancy
Helyszínek itt: Egyesült Államok
- Boston Medical CenterBoston, Egyesült Államok
- University of North Carolina-Chapel HillCarrboro, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.
A vizsgálat 3 csoportja
- Naltrexone
Pregnant women with opioid use disorder on prescribed oral or extended-release naltrexone and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This group will also receive safety and efficacy interventions.
Kezelés: Pharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis és Breast milk analysis
- Buprenorphine/Naloxone
Pregnant women with opioid use disorder on prescribed buprenorphine/naloxone and their infants. Biospecimens collected from this group will undergo genetic and epigenetic analysis and the group will also receive safety and efficacy interventions.
Kezelés: Safety and Efficacy és Genetic and epigenetic analysis
- Naltrexone - alcohol use disorder
Pregnant women with alcohol use disorder on prescribed naltrexone (oral or extended-release) and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This exploratory group will also receive safety and efficacy interventions.
Kezelés: Pharmacokinetic analysis, Genetic and epigenetic analysis és Breast milk analysis
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women
- A regiszteradat frissítve
- 2024. november 4.