EXHIT ENTRE 비교 유효성 시험 (EXHITENTRE)
치료 참여를 강화하기 위한 모범적인 병원 개시 시험 - 오피오이드 사용 장애가 있는 입원 환자를 위한 서방형 부프레노르핀 대 일반적인 치료의 비교 유효성 시험
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The study will randomize approximately 314 hospitalized men and women ages 18 years and older with opioid use disorder (OUD) moderate or severe and who have not been taking prescribed medication for OUD (MOUD) for 14 days or more prior to hospitalization. Eligibility will be determined over one or more assessments during the index hospitalization. Once eligibility has been determined, participants will be randomized 1:1 to either a single injection of extended-release buprenorphine or TAU, which will include methadone, sublingual buprenorphine, or naltrexone. Connection to OUD care and ongoing MOUD following hospitalization will be per community standard. Participants will be assessed for engagement in OUD treatment by the presence of a legitimately prescribed MOUD on day 34 following hospital discharge. Further outcomes will be assessed at 90 and 180 days following hospital discharge.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale New Haven Hospital
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Maryland
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Bayview Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Boston University
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55404
- Hennepin Healthcare Research Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Hospitalized.
- At least 18 years of age.
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
- Willing to initiate MOUD, including buprenorphine.
- Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria:
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Anticipated length of stay less than 24-hours as determined by the ACS
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Affected by a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make it unsafe to participate in the study or may prevent collection of study data. This may include:
- Disabling terminal diagnosis for which discharge from hospital is not anticipated.
- Disabling terminal diagnosis for which hospice care is being sought.
- Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.
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Taking a long-acting opioid other than buprenorphine (e.g., methadone, extended-release oxycodone, extended-release morphine) in the three consecutive days prior to randomization.
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Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.
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Currently pregnant.
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Known allergy to buprenorphine or components of Atrigel delivery system.
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Receipt of MOUD in the 14 days prior to hospitalization as maintenance treatment; however, patients may have received MOUD for withdrawal management during or prior to hospitalization at the time of enrollment.
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Are currently in jail, prison or other overnight facility as required by court of law and/or is considered a prisoner under local law or is under current terms of civil commitment or guardianship.
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Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Interventional
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge. |
XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone).
다른 이름들:
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활성 비교기: Treatment as Usual
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge. |
Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
기간: 34 days post discharge from hospital
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Engagement in OUD is defined as coverage with a legitimately prescribed MOUD on that 34th day regardless of the source of prescribed MOUD coverage (e.g., formalized treatment program, primary care, jail, etc.). |
34 days post discharge from hospital
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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자가 보고된 오피오이드 사용이 있는 참가자의 비율
기간: 퇴원 후 34일, 90일 및 180일
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퇴원 후 34일, 90일 및 180일
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자가 보고된 30일 및 90일 병원 재입원율
기간: 퇴원 후 30일 및 90일
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퇴원 후 30일 및 90일
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자가 보고 30일 및 90일 응급실(ED) 방문 비율
기간: 퇴원 후 30일 및 90일
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퇴원 후 30일 및 90일
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Proportion of participants that experience Adverse Events (AE)
기간: 34 days
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34-days following hospital discharge |
34 days
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Proportion of participants engaged with MOUD
기간: Days 90 and 180 post hospital discharge
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90- and 180-days following hospital discharge |
Days 90 and 180 post hospital discharge
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Proportion of participants with positive urine drug test
기간: Days 34, 90 and 180 post hospital discharge
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for illicit opioids 34-, and 90-, and 180-days following hospital discharge |
Days 34, 90 and 180 post hospital discharge
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Gavin Bart, MD,PhD, Hennepin Healthcare
간행물 및 유용한 링크
일반 간행물
- Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.
- Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.
- Trowbridge P, Weinstein ZM, Kerensky T, Roy P, Regan D, Samet JH, Walley AY. Addiction consultation services - Linking hospitalized patients to outpatient addiction treatment. J Subst Abuse Treat. 2017 Aug;79:1-5. doi: 10.1016/j.jsat.2017.05.007. Epub 2017 May 11.
- Bart G, Barth KS, Baukol P, Enns E, Ghitza UE, Harris J, Jelstrom E, Liebschutz JM, Magane KM, Voronca D, Weinstein ZM, Korthuis PT. Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098 an open-label randomized comparative effectiveness trial of extended-release buprenorphine versus treatment as usual on post-hospital treatment engagement for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2024 Dec 2;19(1):91. doi: 10.1186/s13722-024-00510-5.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NIDA CTN 0098A
- 5UG1DA040316-05 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on the National Institute on Drug Abuse (NIDA) Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. De-identified individual participant data is expected to be made available.
IPD 공유 기간
The data will be shared after the primary outcome paper has been accepted for publication, or 18 months after data lock, whichever comes first. The data will remain indefinitely.
IPD 공유 액세스 기준
Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .