EXHIT ENTRE Ensaio de Eficácia Comparativa (EXHITENTRE)
Teste exemplar de iniciação hospitalar para melhorar o engajamento no tratamento - teste de eficácia comparativa de buprenorfina de liberação prolongada versus tratamento usual para pacientes hospitalizados com transtorno por uso de opioides
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale New Haven Hospital
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston University
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Hennepin Healthcare Research Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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).
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proporção de participantes com uso autorrelatado de opioides
Prazo: Dias 34, 90 e 180 após a alta hospitalar
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Dias 34, 90 e 180 após a alta hospitalar
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Taxas autorrelatadas de readmissão hospitalar em 30 e 90 dias
Prazo: Dias 30 e 90 após a alta hospitalar
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Dias 30 e 90 após a alta hospitalar
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Taxas de visitas ao Departamento de Emergência (DE) autorrelatadas em 30 e 90 dias
Prazo: Dias 30 e 90 após a alta hospitalar
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Dias 30 e 90 após a alta hospitalar
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Proportion of participants that experience Adverse Events (AE)
Prazo: 34 days
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34-days following hospital discharge |
34 days
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Proportion of participants engaged with MOUD
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gavin Bart, MD,PhD, Hennepin Healthcare
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Relacionados a Narcóticos
- Transtornos Mentais, Desordem Mental
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Distúrbios induzidos quimicamente
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Linfoma Não-Hodgkin
- Linfoma
- Doenças hemic e linfáticas
- Distúrbios relacionados a opioides
- Transtornos Relacionados a Substâncias
- Linfoma Folicular
- Preparações farmacêuticas
- Técnicas de investigação
- Tecnologia, farmacêutica
- Formas de dose
- Terapêutica
Outros números de identificação do estudo
- NIDA CTN 0098A
- 5UG1DA040316-05 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
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