- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07642947
Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder (EMBRACE)
A Digitally Enhanced Model of Peer Doula Support for Substance Use Disorder and Peripartum Care
The goal of this pilot study is to learn if a digitally enhanced peer doula program for people with perinatal substance use disorders (PSUD) is feasible and acceptable to patients and staff at two clinics.
Participants will include staff members, such as healthcare providers, recovery support doulas, and administrators, who work at one of the two clinics. It will also include PSUD patients receiving care through the digitally enhanced peer doula program.
Participants will be asked to complete short surveys and take part in a one-time interview with research staff.
This study will also explore engagement in perinatal substance use disorder treatment and prenatal and postpartum visits.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Over the past two decades, rates of substance use during pregnancy have increased fourfold. Overdose is a leading cause of mortality among patients with perinatal substance use disorders (PSUD). Interventions to address SUD during pregnancy and postpartum are critical to reduce mortality and the impact of SUD-related harms for parents and their infants.
Engagement in SUD and perinatal care can improve outcomes for PSUD and their infants, including reducing the risks of preterm delivery and low birthweight. Rates of adequate prenatal care receipt are low for PSUDs, with one recent study estimating that only an estimated 50% of PSUDs in the United States (US) receive adequate prenatal care. These healthcare disparities also extend to the postpartum period, where PSUDs have a 53% decrease in the odds of attending at least one postpartum obstetric visit, compared to patients without an SUD. PSUDs are also less likely to receive SUD treatment during the year postpartum due to lapses in health insurance. Stigma from health professionals and lack of trust in healthcare providers can prevent PSUD from seeking perinatal health services and SUD treatment. PSUD also report numerous barriers to effectively communicating with healthcare providers and want more evidence-based information about delivery, postpartum health, breastfeeding, and the impact of medication for opioid use disorder (MOUD) from their healthcare team. Lack of access to healthcare can have devastating consequences, including a return to substance use and increased risk of fatal overdose. Interventions improving engagement with prenatal and postpartum care and SUD treatment are urgently needed.
A growing body of research suggests that doula care may improve engagement in healthcare for patients with behavioral health conditions. A doula is a trained professional who provides comprehensive physical, emotional, and informational support to patients before, during, and/or after childbirth. Doula care has been widely studied, with reviews suggesting that doula support can decrease rates of preterm birth, Cesarean birth, and low birth weight babies.
Doula care promises to directly improve outcomes and care experiences for PSUD. A growing body of literature has studied how doula support may improve outcomes for patients with behavioral health conditions including postpartum depression and SUD. The Illinois Department of Health/Division of Substance Use Prevention and Recovery pilot specifically use peer doulas, who have dual certifications as certified peer support specialists and doulas. Peer doulas with experience in both SUD and perinatal care could be especially beneficial for PSUD and provide guidance in navigating both SUD and perinatal healthcare systems.
Only one known study has enrolled PSUD to examine their experiences with doula care during pregnancy and postpartum. Twenty-three patients with OUD who had engaged with the Philadelphia doula care model were enrolled in a mixed-methods study examining perceptions of engaging with a doula. Participants overwhelmingly reported positive experiences with the doula program, finding the program acceptable and helpful. They appreciated the ability to engage with the doulas through phone, text, video, or in-person in the community. Participants noted that the doulas helped manage their stress and anxiety, while providing critical assistance navigating the healthcare system. Importantly, participants and staff both agreed that doula involvement reduced perceptions of stigma from healthcare providers.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Elizabeth Saunders, PhD
- Numer telefonu: 603-646-7006
- E-mail: Elizabeth.C.Saunders@dartmouth.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Kathleen Bell, MS
- Numer telefonu: 603-646-7038
- E-mail: kathleen.bell@dartmouth.edu
Lokalizacje studiów
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03766
- Dartmouth Hitchcock Medical Center
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Kontakt:
- Lisa Lamadriz
- Numer telefonu: 603-308-9120
- E-mail: lisa.a.lamadriz@hitchcock.org
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97239
- The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)
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Kontakt:
- Alisa Patten
- Numer telefonu: 971-442-3625
- E-mail: pattena@ohsu.edu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Staff Participant
Inclusion Criteria:
- 18 years of age or older.
Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:
- Provider (including MD, CNM, DO, PA, NP, nurse, medical assistant, behavioral health clinician, social worker, lactation consultant and/or other clinical roles that provide care to patients).
- Peer doulas.
- Administrator (including front desk staff, scheduler, clinic and/or team manager).
- Site leadership.
- Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
Exclusion Criteria:
- Unwilling or unable to provide consent
- Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities
Patient Participant (Cohort 1 & Cohort 2)
Inclusion Criteria
- 18 years of age or older
Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services
•Either
Not currently engaged in the digitally enhanced peer doula model and no prior exposure to the model or less than 30 days exposure to the model if newly enrolled, AND currently pregnant or up to 6 weeks postpartum.
OR
- Currently engaged in the digitally enhanced peer doula model for more than 30 days, AND currently pregnant or up to one year postpartum
- Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
Exclusion Criteria:
- Unable or unwilling to provide consent to participate in study activities
- Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities
- Currently unable to engage in the digitally enhanced peer doula model or attend research visits
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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Patient Participants Cohort 1
Patient Participants who have not yet been exposed to the peer doula model of care or have been exposed for less than 30 days
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In the digitally enhanced peer doula model of care, patients with perinatal substance use disorder are partnered with a recovery support peer doula who is able to provide synchronous or asynchronous support.
This support can include in-person and text-based and/or telehealth support, in addition to assistance scheduling and arranging transport to appointments for both SUD and peripartum care, and assisting with access to food, transportation and housing.
Additionally, these patients are offered a free smartphone and data plan for pregnancy and one-year postpartum.
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Patient Participants Cohort 2
Patient Participants who have been exposed to the peer doula model of care for at least 30 days
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In the digitally enhanced peer doula model of care, patients with perinatal substance use disorder are partnered with a recovery support peer doula who is able to provide synchronous or asynchronous support.
This support can include in-person and text-based and/or telehealth support, in addition to assistance scheduling and arranging transport to appointments for both SUD and peripartum care, and assisting with access to food, transportation and housing.
Additionally, these patients are offered a free smartphone and data plan for pregnancy and one-year postpartum.
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Site Staff Participants
Site staff participants who have been exposed to the peer doula model of care at their clinical site
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Feasibility of Intervention Measure (FIM)
Ramy czasowe: At enrollment
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Site staff participants will complete the FIM, a 4-item survey, that examines the feasibility of implementing the digitally enhanced peer doula model in routine obstetric settings. Using a five-point Likert scale, the FIM has 4 items examining whether an innovation is implementable, possible, doable, and easy to use. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater feasibility. Two versions of the FIM will be completed by Site staff participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the FIM will assess the acceptability of the peer doula component of the model. |
At enrollment
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Acceptability of Intervention Measures (AIM)
Ramy czasowe: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)
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Site staff and patient participants will complete the AIM, a 4-item survey, that assesses the acceptability of the digitally enhanced peer doula model in routine obstetric settings. The survey asks participants to rate the acceptability of the model from completely disagree to completely agree. Using a five-point Likert scale, the AIM has 4 items examining whether an innovation meets participant approval, is appealing, is welcomed, and is liked. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater acceptability. Two versions of the AIM will be completed by patient participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the AIM will assess the acceptability of the peer doula component of the model. Site staff will only complete the second version. . |
At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Prenatal Obstetric Visits
Ramy czasowe: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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The number of prenatal visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model. Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort. |
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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Number of Postpartum Obstetric Visits
Ramy czasowe: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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The number of postpartum visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model.
Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort.
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Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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Engagement in substance use disorder (SUD) treatment
Ramy czasowe: At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
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Engagement in substance use disorder (SUD) treatment will be assessed via the Oregon Hope Engagement in Addiction Treatment Survey (OR HOPE). This will be measured by evaluating the percentage of patients reporting participation in SUD services before and after exposure to the model. Items measured will be the following:
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At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
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Engagement in Peer Doula Support
Ramy czasowe: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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Sites will abstract data from each peer doula contact with study participants. This data will include the following:
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Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Lisa A. Marsch, PhD, Dartmouth College
Publikacje i pomocne linki
Publikacje ogólne
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths From Suicide and Overdose in Colorado, 2004-2012. Obstet Gynecol. 2016 Dec;128(6):1233-1240. doi: 10.1097/AOG.0000000000001695.
- Ecker J, Abuhamad A, Hill W, Bailit J, Bateman BT, Berghella V, Blake-Lamb T, Guille C, Landau R, Minkoff H, Prabhu M, Rosenthal E, Terplan M, Wright TE, Yonkers KA. Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine. Am J Obstet Gynecol. 2019 Jul;221(1):B5-B28. doi: 10.1016/j.ajog.2019.03.022. Epub 2019 Mar 27. No abstract available.
- Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
- Gjerdingen DK, McGovern P, Pratt R, Johnson L, Crow S. Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. J Prim Care Community Health. 2013 Jan;4(1):36-43. doi: 10.1177/2150131912451598. Epub 2012 Jun 20.
- Ruiz MG, Dronamraju R. Utilizing doula care to support substance use disorder in the postpartum period. Association of State and Territorial Health Officials,, 2023.
- Gannon M, Hand D, Short VL, Carrubba T, Thiele G, Pancoe S, Lawson S, Haerizadeh-Yazdi N, Keith SW, Abatemarco D. "Someone is there with you through this [pregnancy] that isn't seeing you through a negative lens": Considerations for integrating doula referrals into opioid treatment programs. J Subst Use Addict Treat. 2025 Feb;169:209585. doi: 10.1016/j.josat.2024.209585. Epub 2024 Nov 17.
- Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1.
- Nidey N, Kair LR, Wilder C, Froehlich TE, Weber S, Folger A, Marcotte M, Tabb K, Bowers K. Substance Use and Utilization of Prenatal and Postpartum Care. J Addict Med. 2022 Jan-Feb 01;16(1):84-92. doi: 10.1097/ADM.0000000000000843.
- Han B, Compton WM, Einstein EB, Elder E, Volkow ND. Pregnancy and Postpartum Drug Overdose Deaths in the US Before and During the COVID-19 Pandemic. JAMA Psychiatry. 2024 Mar 1;81(3):270-283. doi: 10.1001/jamapsychiatry.2023.4523.
- Mazel S, Alexander K, Cioffi C, Terplan M. Interventions to Support Engagement in Addiction Care Postpartum: Principles and Pitfalls. Subst Abuse Rehabil. 2023 Jul 3;14:49-59. doi: 10.2147/SAR.S375652. eCollection 2023.
- Goldman-Mellor S, Margerison CE. Maternal drug-related death and suicide are leading causes of postpartum death in California. Am J Obstet Gynecol. 2019 Nov;221(5):489.e1-489.e9. doi: 10.1016/j.ajog.2019.05.045. Epub 2019 Jun 4.
- Bruzelius E, Martins SS. US Trends in Drug Overdose Mortality Among Pregnant and Postpartum Persons, 2017-2020. JAMA. 2022 Dec 6;328(21):2159-2161. doi: 10.1001/jama.2022.17045.
- Eliason EL, Gordon SH. The Association Between Postpartum Insurance Instability and Access to Postpartum Mental Health Services: Evidence From Colorado. Womens Health Issues. 2022 Nov-Dec;32(6):550-556. doi: 10.1016/j.whi.2022.06.010. Epub 2022 Aug 1.
- Scroggins JK, Harkins SE, Brown S, St Clair V, LeBron GK, Barcelona V. A systematic review of community-based interventions to address perinatal mental health. Semin Perinatol. 2024 Oct;48(6):151945. doi: 10.1016/j.semperi.2024.151945. Epub 2024 Jul 14.
- Haerizadeh-Yazdi N, Huynh MP, Narva A, Grasty A, Lemon M, Claxton N, Gillespie K, Kallem S. Philadelphia Department of Health Doula Support Program: Early Successes and Challenges of a Program Serving Birthing People Affected by Substance Use Disorder. Matern Child Health J. 2023 Dec;27(Suppl 1):52-57. doi: 10.1007/s10995-023-03803-4. Epub 2023 Nov 9.
- Klaman SL, Isaacs K, Leopold A, Perpich J, Hayashi S, Vender J, Campopiano M, Jones HE. Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance. J Addict Med. 2017 May/Jun;11(3):178-190. doi: 10.1097/ADM.0000000000000308.
- Schiff DM, Nielsen T, Terplan M, Hood M, Bernson D, Diop H, Bharel M, Wilens TE, LaRochelle M, Walley AY, Land T. Fatal and Nonfatal Overdose Among Pregnant and Postpartum Women in Massachusetts. Obstet Gynecol. 2018 Aug;132(2):466-474. doi: 10.1097/AOG.0000000000002734.
- Quiray J, Richards E, Navarro-Aguirre Y, Glazer D, Adachi J, Trujillo E, Perera D, Garcia EP, Bhat A. The role of doulas in supporting perinatal mental health - a qualitative study. Front Psychiatry. 2024 Feb 29;15:1272513. doi: 10.3389/fpsyt.2024.1272513. eCollection 2024.
- Gannon M, Short V, Becker M, Parikh S, McGuigan K, Hand D, Keith S, Abatemarco D. Doula engagement and maternal opioid use disorder (OUD): Experiences of women in OUD recovery during the perinatal period. Midwifery. 2022 Mar;106:103243. doi: 10.1016/j.midw.2021.103243. Epub 2021 Dec 30.
- McComish JF, Groh CJ, Moldenhauer JA. Development of a doula intervention for postpartum depressive symptoms: participants' recommendations. J Child Adolesc Psychiatr Nurs. 2013 Feb;26(1):3-15. doi: 10.1111/jcap.12019. Epub 2013 Jan 2.
- Hall EM, Forman S, Ostfeld BM, Shahidullah JD. Doula support for perinatal mental health needs: Perspectives on training and practice. Midwifery. 2025 Feb;141:104275. doi: 10.1016/j.midw.2024.104275. Epub 2024 Dec 20.
- Alvarado G, Schultz D, Malika N, Reed N. United States Doula Programs and Their Outcomes: A Scoping Review to Inform State-Level Policies. Womens Health Issues. 2024 Jul-Aug;34(4):350-360. doi: 10.1016/j.whi.2024.03.001. Epub 2024 May 9.
- Ramey-Collier K, Jackson M, Malloy A, McMillan C, Scraders-Pyatt A, Wheeler SM. Doula Care: A Review of Outcomes and Impact on Birth Experience. Obstet Gynecol Surv. 2023 Feb;78(2):124-127. doi: 10.1097/OGX.0000000000001103.
- DONA International. What is a doula? Chicago, IL2025. Available from: https://www.dona.org/what-is-a-doula-2/.
- Haiman MD, Johnson KA, Horan H, Bradley LJ, Albright DL. Addressing Gaps and Saving Lives: Doulas' Role in Addressing Substance Use and Mental Health Challenges Among Pregnant and Postpartum Clients-A Scoping Review. Matern Child Health J. 2024 Feb;28(2):246-252. doi: 10.1007/s10995-023-03832-z. Epub 2023 Nov 10.
- Alexander K, Short V, Gannon M, Goyal N, Naegle M, Abatemarco DJ. Identified gaps and opportunities in perinatal healthcare delivery for women in treatment for opioid use disorder. Subst Abus. 2021;42(4):552-558. doi: 10.1080/08897077.2020.1803178. Epub 2020 Aug 19.
- Renbarger KM, Shieh C, Moorman M, Latham-Mintus K, Draucker C. Health Care Encounters of Pregnant and Postpartum Women with Substance Use Disorders. West J Nurs Res. 2020 Aug;42(8):612-628. doi: 10.1177/0193945919893372. Epub 2019 Dec 20.
- Daw JR, Hatfield LA, Swartz K, Sommers BD. Women In The United States Experience High Rates Of Coverage 'Churn' In Months Before And After Childbirth. Health Aff (Millwood). 2017 Apr 1;36(4):598-606. doi: 10.1377/hlthaff.2016.1241.
- Bailey BA, Byrom AR. Factors predicting birth weight in a low-risk sample: the role of modifiable pregnancy health behaviors. Matern Child Health J. 2007 Mar;11(2):173-9. doi: 10.1007/s10995-006-0150-7. Epub 2006 Nov 8.
- El-Mohandes A, Herman AA, Nabil El-Khorazaty M, Katta PS, White D, Grylack L. Prenatal care reduces the impact of illicit drug use on perinatal outcomes. J Perinatol. 2003 Jul-Aug;23(5):354-60. doi: 10.1038/sj.jp.7210933.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CTN-0157
- UG1DA040309 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Używanie substancji okołoporodowych
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Assistance Publique - Hôpitaux de ParisMission Interministérielle de Lutte contre les Drogues et les Conduites Addictives... i inni współpracownicyZakończonyKonsumpcja substancji psychoaktywnych | Zaburzenie związane z substancjami | Off Label-use | Wzmocnienie funkcji poznawczychFrancja